ID

15764

Descripción

NCT02669589 EudraCT-Nr. 2014-004854 [Titel anhand dieser ISBN in Citavi-Projekt übernehmen] -33 REGIONAL CITRATE VERSUS SYSTEMIC HEPARIN ANTICOAGULATION FOR CONTINUOUS RENAL REPLACEMENT THERAPY IN CRITICALLY ILL PATIENTS WITH ACUTE KIDNEY INJURY Study Chair: Alexander Zarbock, MD University Hospital Muenster

Palabras clave

N17

Klinische Studie [Dokumenttyp]

D017582

Dokumentation

12/6/16 12/6/16 -

Subido en

12 de junio de 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC-ND 3.0

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Baseline RICH study NCT02669589

model
Detalles

Baseline RICH study NCT02669589

1 formularios

StudyEvent: ODM
1. Baseline RICH study NCT02669589

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de datos

Alias

Patient Information

Item Group

Patient Information

C1955348 (UMLS CUI-1)

Center ID

Item

ID of Center

text

C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])

Patient ID

Item

ID of patient

text

C2348585 (UMLS CUI [1])

Patient Data

Item Group

Patient Data

C2707520 (UMLS CUI-1)

Age

Item

Patient's age

float

Body weight

Item

Patient's body weight

float

C0005910 (UMLS CUI [1])

Body height

Item

Patient's body height

float

C0005890 (UMLS CUI [1])

Date of admission

Item

Date of admission to hospital

date

C1302393 (UMLS CUI [1])

Date of admission to ICU

Item

Date of admission to ICU

date

C1302393 (UMLS CUI [1,1])
C0583239 (UMLS CUI [1,2])

Time of admission to ICU

Item

Time of admission to ICU

time

C3854259 (UMLS CUI [1,1])
C0583239 (UMLS CUI [1,2])

Admission to ICU: transfer

Item

From which department was the patient transferred to ICU?

text

C0030704 (UMLS CUI [1,1])
C0583239 (UMLS CUI [1,2])

Admission to ICU: transfer

Code List

From which department was the patient transferred to ICU?

CL Item

operating room (operating room)

CL Item

other ICU (other ICU)

CL Item

emergency room (emergency room)

CL Item

directly (emergency ambulance/ medevac chopper) (directly (emergency ambulance/ medevac chopper))

CL Item

other hospital (other hospital)

Reason for admission to ICU

Item

Reason for admission:

text

C0392360 (UMLS CUI [1,1])
C0583239 (UMLS CUI [1,2])

Reason for admission to ICU

Code List

Reason for admission:

CL Item

internistically (internistically)

CL Item

surgically (surgically)

Emergency situation

Item

Emergency situation

boolean

C0013956 (UMLS CUI [1])

Indication for RRT: start date

Item

Indication for RRT: start date

date

C0392360 (UMLS CUI [1,1])
C0206074 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])

Indication for RRT: start time

Item

Indication for RRT: start time

time

C0392360 (UMLS CUI [1,1])
C0206074 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])

Kidney Disease: Improving Global Outcomes (KDIGO)

Item Group

Kidney Disease: Improving Global Outcomes (KDIGO)

C0022658 (UMLS CUI-1)
C0008902 (UMLS CUI-2)

Serum Creatinine

Item

Serum Creatinine

float

C0201976 (UMLS CUI [1])

Urinary excretion

Item

Urinary excretion

float

C0042034 (UMLS CUI [1])

KDIGO: Kidney Disease Classification

Item

KDIGO: Kidney Disease Classification

text

C0022658 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])

KDIGO: Kidney Disease Classification

Code List

KDIGO: Kidney Disease Classification

CL Item

KDIGO I (Serum creatinine: increase about 0,3 mg/dL (within 48h) OR increase about 1,5 - 1,9 times (within 7d); urinary excretion < 0,5 ml/kgKG/h for 6-12h) (KDIGO I (Serum creatinine: increase about 0,3 mg/dL (within 48h) OR increase about 1,5 - 1,9 times (within 7d); urinary excretion < 0,5 ml/kgKG/h for 6-12h))

CL Item

KDIGO II (Serum creatinine: increase about 2 - 2,9 times; urinary excretion < 0,5 ml/kgKG/h for ≥12h) (KDIGO II (Serum creatinine: increase about 2 - 2,9 times; urinary excretion < 0,5 ml/kgKG/h for ≥12h))

CL Item

KDIGO III (Serum creatinine: increase about ≥3 times OR increase up to ≥4 mg/dL OR start of Renal Replacement Therapy OR Patient < 18 y/o: decrease of eGFR <35mL/min/1,73m2; urinary excretion: <0,3ml/kgKG/h for ≥24h OR anuria for ≥12h) (KDIGO III (Serum creatinine: increase about ≥3 times OR increase up to ≥4 mg/dL OR start of Renal Replacement Therapy OR Patient < 18 y/o: decrease of eGFR <35mL/min/1,73m2; urinary excretion: <0,3ml/kgKG/h for ≥24h OR anuria for ≥12h))

KDIGO: start date

Item

Start Date of specific KDIGO classification:

date

C0808070 (UMLS CUI [1])

KDIGO: start time

Item

Start Time of specific KDIGO classification:

time

C1301880 (UMLS CUI [1])

KDIGO: end date

Item

End Date of specific KDIGO classification:

date

C0806020 (UMLS CUI [1])

KDIGO: end time

Item

End Time of specific KDIGO classification:

time

C1522314 (UMLS CUI [1])

Renal function

Item Group

Renal function (suspected reason for acute kidney failure)

C0232804 (UMLS CUI-1)

Reason for acute kidney failure

Item

Known reason for acute kidney failure?

boolean

C0022660 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])

Sepsis

Item

Sepsis?

boolean

C0243026 (UMLS CUI [1])

Nephrotoxin

Item

Nephrotoxin?

boolean

C4062437 (UMLS CUI [1])

Surgical intervention

Item

Surgical intervention?

boolean

C4035998 (UMLS CUI [1])

Cardiac surgical intervention with heart-lung machine

Item

Cardiac surgical intervention with heart-lung machine?

boolean

C0018821 (UMLS CUI [1,1])
C0018830 (UMLS CUI [1,2])

Heart failure

Item

Heart failure?

boolean

C0018801 (UMLS CUI [1])

Hepatorenal syndrome

Item

Hepatorenal syndrome?

boolean

C0019212 (UMLS CUI [1])

Pre-renal renal failure

Item

Pre-renal renal failure?

boolean

C3854173 (UMLS CUI [1])

Ischemia

Item

Ischemia?

boolean

C0022116 (UMLS CUI [1])

Creatinine measurement

Item

Increased serum creatinine?

text

C0201976 (UMLS CUI [1])

Creatinine measurement

Code List

Increased serum creatinine?

CL Item

no incrase/ increase < 1,5 times (no incrase/ increase < 1,5 times)

CL Item

increase ≥ 1,5 - 1,9 times (increase ≥ 1,5 - 1,9 times)

CL Item

≥ 0,3 mg/dL (26,4 μmol/L) within 48 h (≥ 0,3 mg/dL (26,4 μmol/L) within 48 h)

CL Item

increase 2 - 2,9 times within 7 d (increase 2 - 2,9 times within 7 d)

CL Item

increase ≥ 3 times within 7 d (increase ≥ 3 times within 7 d)

CL Item

increase ≥ 4 mg (354 μmol/L) with acute increase about at least 0,5 mg/dL (44 μmol/L) within 7 d (increase ≥ 4 mg (354 μmol/L) with acute increase about at least 0,5 mg/dL (44 μmol/L) within 7 d)

Urinary excretion measurement

Item

Urinary excretion within the last 24h?

text

C1285928 (UMLS CUI [1])

Urinary excretion measurement

Code List

Urinary excretion within the last 24h?

CL Item

≥ 0,5 mL/kg/h for ≥ 6h (≥ 0,5 mL/kg/h for ≥ 6h)

CL Item

< 0,5 mL/kg/h for ≥ 6h (< 0,5 mL/kg/h for ≥ 6h)

CL Item

< 0,5 mL/kg/h for ≥ 12h (< 0,5 mL/kg/h for ≥ 12h)

CL Item

< 0,3 mL/kg/h for ≥ 24h or anuria for ≥ 12h (< 0,3 mL/kg/h for ≥ 24h or anuria for ≥ 12h)

Urinary excretion measurement accuracy

Item

Urinary excretion measurement accuracy?

text

C1285928 (UMLS CUI [1,1])
C0443131 (UMLS CUI [1,2])

Urinary excretion measurement accuracy

Code List

Urinary excretion measurement accuracy?

CL Item

measured (measured)

CL Item

estimated (estimated)

Clinical indication for RRT

Item

Clinical indication for renal replacement therapy?

text

C0392360 (UMLS CUI [1,1])
C0206074 (UMLS CUI [1,2])

Clinical indication for RRT

Code List

Clinical indication for renal replacement therapy?

CL Item

no (no)

CL Item

serum urea > 150 mg/dL (serum urea > 150 mg/dL)

CL Item

serum potassium > 6 mmol/L (serum potassium > 6 mmol/L)

CL Item

serum magnesium > 4 mmol/L or anuria (serum magnesium > 4 mmol/L or anuria)

CL Item

blood pH < 7.15 (blood pH < 7.15)

CL Item

urinary production < 200 mL/12h or anuria (urinary production < 200 mL/12h or anuria)

CL Item

oedema in organs in context of AKI, despite diuretics (oedema in organs in context of AKI, despite diuretics)

Neurologic dysfunction

Item Group

Neurologic dysfunction (at screening)

C0751377 (UMLS CUI-1)

Coma, stupor, decreased vigilance, delirium

Item

Coma, stupor, decreased vigilance, delirium?

boolean

C0009421 (UMLS CUI [1])
C0085628 (UMLS CUI [2])
C0920048 (UMLS CUI [3])
C0011206 (UMLS CUI [4])

Epileptic seizure

Item

Epileptic seizure?

boolean

C1411824 (UMLS CUI [1])

Focal Neurologic Deficits

Item

Focal Neurologic Deficits?

boolean

C0746857 (UMLS CUI [1])

Intracranial Hemorrhage

Item

Intracranial Hemorrhage?

boolean

C0151699 (UMLS CUI [1])

Intracranial mass

Item

Intracranial mass?

boolean

C0270614 (UMLS CUI [1])

Pulmonary dysfunction

Item Group

Pulmonary dysfunction (respiratory insufficiency) (at screening)

C1709770 (UMLS CUI-1)

COPD

Item

Chronic Obstructive Pulmonary Disease?

boolean

C0024117 (UMLS CUI [1])

Aspiration

Item

Aspiration?

boolean

C0349707 (UMLS CUI [1])

Pneumonia

Item

Pneumonia?

boolean

C0032285 (UMLS CUI [1])

ARDS

Item

Acute Respiratory Distress Syndrome?

boolean

C0035222 (UMLS CUI [1])

Pulmonary embolism

Item

Pulmonary embolism?

boolean

C0034065 (UMLS CUI [1])

Cardiovascular disorder

Item Group

Cardiovascular disorder (at screening)

C0007222 (UMLS CUI-1)

Cardiac arrest with necessary resuscitation

Item

Cardiac arrest with necessary resuscitation?

boolean

C0018790 (UMLS CUI [1,1])
C0007203 (UMLS CUI [1,2])

Septic shock

Item

Septic shock?

boolean

C0036983 (UMLS CUI [1])

Cardiogenic shock

Item

Cardiogenic shock

boolean

C0036980 (UMLS CUI [1])

Haemorrhagic shock

Item

Haemorrhagic shock

boolean

C0036982 (UMLS CUI [1])

Acute coronary syndrome

Item

Acute coronary syndrome?

boolean

C0948089 (UMLS CUI [1])

Supraventricular arrhythmia

Item

Supraventricular arrhythmia?

boolean

C0428974 (UMLS CUI [1])

Ventricular arrhythmia

Item

Ventricular arrhythmia?

boolean

C0085612 (UMLS CUI [1])

Hypertensive crisis

Item

Hypertensive crisis?

boolean

C0020546 (UMLS CUI [1])

Heart failure

Item

Heart failure without shock

boolean

C0018801 (UMLS CUI [1])

Gastrointestinal dysfunction

Item Group

Gastrointestinal dysfunction (at screening)

C0679407 (UMLS CUI-1)

Severe pancreatitis

Item

Severe pancreatitis?

boolean

C0030305 (UMLS CUI [1])

Acute abdomen

Item

Acute abdomen?

boolean

C0000727 (UMLS CUI [1])

Acute liver failure

Item

Acute liver failure?

boolean

C0162557 (UMLS CUI [1])

Chronic liver failure

Item

Chronic liver failure?

boolean

C2936476 (UMLS CUI [1])

Other organ dysfunction

Item Group

Other organ dysfunction (at screeing)

C0349410 (UMLS CUI-1)

Sepsis

Item

Sepsis?

boolean

C0243026 (UMLS CUI [1])

Severe trauma

Item

Severe trauma?

boolean

C3714660 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])

Gynaecological/ obstetric dysfunction

Item

Gynaecological/ obstetric dysfunction?

boolean

C0017411 (UMLS CUI [1])
C0205484 (UMLS CUI [2])

Post-operative care

Item

Post-operative care?

boolean

C2112579 (UMLS CUI [1])

Other reasons

Item

Other reasons?

boolean

C0205394 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])

Other reasons: specification

Item

If other reason, specify:

text

C0205394 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])

Main diagnosis for admission

Item Group

Main diagnosis for admission

C0332137 (UMLS CUI-1)
C0030673 (UMLS CUI-2)

Main diagnosis for admission

Item

Main diagnosis for admission: (Diagnosis which permits admission to ICU)

text

C0332137 (UMLS CUI [1,1])
C0030673 (UMLS CUI [1,2])

Main diagnosis for admission

Code List

Main diagnosis for admission: (Diagnosis which permits admission to ICU)

CL Item

Cardiac surgery (Cardiac surgery)

CL Item

Vascular surgery (Vascular surgery)

CL Item

Abdominal surgery (Abdominal surgery)

CL Item

Trauma (Trauma)

CL Item

Pneumonia/ ARDS (Pneumonia/ ARDS)

CL Item

Cardiogenic shock (Cardiogenic shock)

CL Item

Sepsis (Sepsis)

CL Item

Pancreatitis (Pancreatitis)

CL Item

Heart failure (Heart failure)

CL Item

Liver failure (Liver failure)

CL Item

Acute Kidney Injury (Acute Kidney Injury)

CL Item

Abdominal infections (Abdominal infections)

CL Item

Other (Other)

Pre-existing illness

Item Group

Pre-existing illness

C0521987 (UMLS CUI-1)

Myocardial Infarction

Item

Myocardial Infarction

boolean

C0027051 (UMLS CUI [1])

Heart failure - NYHA

Item

Heart failure - NYHA

text

C1275491 (UMLS CUI [1])

Heart failure - NYHA

Code List

Heart failure - NYHA

CL Item

NYHA I (NYHA I)

CL Item

NYHA II (NYHA II)

CL Item

NYHA III (NYHA III)

CL Item

NYHA IV (NYHA IV)

CL Item

no NYHA (no NYHA)

Ejection fraction

Item

Ejection fraction

float

C0232174 (UMLS CUI [1])

Cardiac arrhythmia

Item

Cardiac arrhythmia

boolean

C0003811 (UMLS CUI [1])

Valvular heart disease

Item

Valvular heart disease

boolean

C0018824 (UMLS CUI [1])

Peripheral arterial occlusive disease

Item

Peripheral arterial occlusive disease

boolean

C1306889 (UMLS CUI [1])

Cerebrovascular disease

Item

Cerebrovascular disease

boolean

C0007820 (UMLS CUI [1])

Stroke

Item

Stroke

boolean

C0038454 (UMLS CUI [1])

Pulmonary fibrosis

Item

Pulmonary fibrosis

boolean

C0034069 (UMLS CUI [1])

Chronic lung disease

Item

Other severe chronic lung disease (Climbing stairs or housework not possible)

boolean

C0746102 (UMLS CUI [1])

Chronic hypoxia

Item

Proven chronic hypoxia

boolean

C0745190 (UMLS CUI [1])

Secondary polycythemia

Item

Secondary polycythemia

boolean

C1318533 (UMLS CUI [1])

Pulmonary Hypertension

Item

Severe pulmonary hypertension (> 40 mmHg)

boolean

C0020542 (UMLS CUI [1])

Home mechanical ventilation

Item

Home mechanical ventilation

boolean

C4039825 (UMLS CUI [1])

Rheumatoid arthritis

Item

Rheumatoid arthritis

boolean

C0003873 (UMLS CUI [1])

Gastric/ Duodenal ulcer

Item

Gastric/ Duodenal ulcer

boolean

C0013295 (UMLS CUI [1])
C0038358 (UMLS CUI [2])

Liver cirrhosis

Item

Liver cirrhosis

boolean

C0023890 (UMLS CUI [1])

Portal hypertension

Item

Proven portal hypertension

boolean

C0020541 (UMLS CUI [1])

Oesophageal variceal bleeding

Item

Eearly oesophageal variceal bleeding

boolean

C2062316 (UMLS CUI [1])

Hepatic encephalopathy/ coma

Item

Hepatic encephalopathy/ coma

boolean

C0019151 (UMLS CUI [1])
C0019147 (UMLS CUI [2])

Diabetes mellitus

Item

Diabetes mellitus without organ complication

boolean

C0011849 (UMLS CUI [1])

Diabetes mellitus with organ complication

Item

Diabetes mellitus with organ complication

boolean

C0011849 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])

Alcohol abuse

Item

Alcohol abuse

boolean

C0038586 (UMLS CUI [1])

Leukemia

Item

Leukemia

boolean

C0023418 (UMLS CUI [1])

Solid tumor

Item

Solid tumor

boolean

C0280100 (UMLS CUI [1])

Solid tumor: metastatic

Item

Solid tumor: metastatic

boolean

C0280100 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])

Haematologic malignancy

Item

Haematologic malignancy

boolean

C0376545 (UMLS CUI [1])

Haematologic malignancy: metastatic

Item

Haematologic malignancy: metastatic

boolean

C0376545 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])

Chemotherapy

Item

Chemotherapy (until 30 days before admission)

boolean

C0392920 (UMLS CUI [1])

Radiation

Item

Radiation

boolean

C0851346 (UMLS CUI [1])

Therapeutic Immunosuppression

Item

Therapeutic Immunosuppression due to organ transplantation

boolean

C0021079 (UMLS CUI [1])

AIDS

Item

AIDS

boolean

C0001175 (UMLS CUI [1])

High dose steroids

Item

High dose steroids (above cushing threshold (> 7.5 mg Decortin/d) for > 3 d)

boolean

C0038317 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])

Premedication

Item Group

Premedication (existing at admission)

C0033045 (UMLS CUI-1)

Antiplatelet therapy

Item

Antiplatelet therapy

boolean

C1096021 (UMLS CUI [1])

ACE inhibitor

Item

ACE inhibitor

boolean

C0003015 (UMLS CUI [1])

Angiotensin Receptor Antagonists

Item

Angiotensin Receptor Antagonists

boolean

C0815017 (UMLS CUI [1])

Beta-Antagonists

Item

Beta-Antagonists

boolean

C0001645 (UMLS CUI [1])

Diuretics

Item

Diuretics

boolean

C0012798 (UMLS CUI [1])

Statins

Item

Statins

boolean

C0360714 (UMLS CUI [1])

Premedication

Item

Other premedication

boolean

C0033045 (UMLS CUI [1])

Premedication: specification

Item

If other premedication, specify agent:

text

C0033045 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])

Glasgow Coma Scale

Item Group

Glasgow Coma Scale (24h before randomisation) (if analog sedated patients, please regard to Working Instruction!)

C0017594 (UMLS CUI-1)

Eye opening

Item

Eye opening: 4 - Opens eyes spontaneously 3 - Opens eyes in response to voice 2 - Opens eyes in response to painful stimuli 1 - Does not open eyes 2

float

C0559289 (UMLS CUI [1])

Verbal response

Item

Verbal response: 5 - Oriented, converses normally 4 - Confused, disoriented 3 - Utters inappropriate words 2 - Incomprehensible sounds 1 - Makes no sounds

float

C0559291 (UMLS CUI [1])

Motor response

Item

Motor response: 6 - Obeys commands 5 - Localizes painful stimuli 4 - Flexion / Withdrawal to painful stimuli 3 - Abnormal flexion to painful stimuli 2 - Extension to painful stimuli 1 - Makes no movements

float

C0559290 (UMLS CUI [1])

Estimated

Item

Was Glasgow Coma Scale estimated?

boolean

C0750572 (UMLS CUI [1])

Mechanical ventilation

Item Group

Mechanical ventilation (24h before randomisation)

C0199470 (UMLS CUI-1)

Mechanical ventilation

Item

Please specify the most severe form of ventilation which was used:

text

C0199470 (UMLS CUI [1])

Mechanical ventilation

Code List

Please specify the most severe form of ventilation which was used:

CL Item

no ventilation (no ventilation)

CL Item

non-invasive ventilation (non-invasive ventilation)

CL Item

invasive ventilation (invasive ventilation)

Catecholamine and inotropic therapy

Item Group

Catecholamine and inotropic therapy

C0007412 (UMLS CUI-1)
C0304509 (UMLS CUI-3)

Catecholamine and inotropic therapy

Item

Use of Catecholamine or inotropic therapy? (24h before randomisation)

boolean

C0007412 (UMLS CUI [1])
C0304509 (UMLS CUI [2])

Adrenaline

Item

Adrenaline therapy?

boolean

C0014563 (UMLS CUI [1])

Adrenaline dosage

Item

Adrenaline therapy: If "Yes", specify highest dosage over at least 1h: (possible units μg/ kg/ min or μg/ min or mg/h)

float

C0014563 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])

Noradrenaline

Item

Noradrenaline therapy?

boolean

C0028351 (UMLS CUI [1])

Noradrenaline dosage

Item

Noradrenaline therapy: If "Yes", specify highest dosage over at least 1h: (possible units μg/ kg/ min or μg/ min or mg/h)

float

C0028351 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])

Dobutamine

Item

Dobutamine therapy?

boolean

C0012963 (UMLS CUI [1])

Dobutamine dosage

Item

Dobutamine therapy: If "Yes", specify highest dosage over at least 1h: (possible units μg/ kg/ min or μg/ min or mg/h)

float

C0012963 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])

Vasopressins

Item

Vasopressins therapy?

boolean

C0042413 (UMLS CUI [1])

Vasopressins dosage

Item

Vasopressins therapy: If "Yes", specify highest dosage over at least 1h:

float

C0042413 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])

Terlipressin

Item

Terlipressin therapy?

boolean

C0145185 (UMLS CUI [1])

Milrinone

Item

Milrinone therapy?

boolean

C0128513 (UMLS CUI [1])

Milrinone dosage

Item

Milrinone therapy: If "Yes", specify highest dosage over at least 1h: (possible units μg/ kg/ min or mg/h)

float

C0128513 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])

Levosimendan

Item

Levosimendan therapy?

boolean

C0246904 (UMLS CUI [1])

Levosimendan dosage

Item

Levosimendan therapy: If "Yes", specify highest dosage over at least 1h:

float

C0246904 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])

Vital signs

Item Group

Vital signs

C0518766 (UMLS CUI-1)

Body temperature: Minimum

Item

Body temperature: Minimum

float

C0886414 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Body temperature: Maximum

Item

Body temperature: Maximum

float

C0886414 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Systolic blood pressure: Minimum

Item

Systolic blood pressure: Minimum

float

C0871470 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Systolic blood pressure: Maximum

Item

Systolic blood pressure: Maximum

float

C0871470 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Mean arterial pressure: Minimum

Item

Mean arterial pressure: Minimum

float

C0428886 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Mean arterial pressure: Maximum

Item

Mean arterial pressure: Maximum

float

C0428886 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Diastolic blood pressure: Minimum

Item

Diastolic blood pressure: Minimum

float

C0428883 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Diastolic blood pressure: Maximum

Item

Diastolic blood pressure: Maximum

float

C0428883 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Heart rate: Minimum

Item

Heart rate: Minimum

float

C0018810 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Heart rate: Maximum

Item

Heart rate: Maximum

float

C0018810 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Respiratory rate: Minimum

Item

Respiratory rate: Minimum

float

C0231832 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Respiratory rate: Maximum

Item

Respiratory rate: Maximum

float

C0231832 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Central venous pressure: Minimum

Item

Central venous pressure: Minimum

float

C0199666 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Central venous pressure: Maximum

Item

Central venous pressure: Maximum

float

C0199666 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

ECMO

Item

ECMO therapy?

boolean

C0015357 (UMLS CUI [1])

Intra-aortic balloon pump

Item

Intra-aortic balloon pump therapy?

boolean

C0021860 (UMLS CUI [1])

Concomitant medication

Item Group

Concomitant medication (within the last 24h before randomisation)

C2347852 (UMLS CUI-1)

Diuretics

Item

Diuretics?

boolean

C0012798 (UMLS CUI [1])

X-ray contrast media

Item

X-ray contrast media?

boolean

C0358510 (UMLS CUI [1])

Aminoglycosides

Item

Aminoglycosides?

boolean

C0002556 (UMLS CUI [1])

Amphotericin

Item

Amphotericin?

boolean

C0085795 (UMLS CUI [1])

Vancomycin

Item

Vancomycin?

boolean

C0042313 (UMLS CUI [1])

Low molecular weight heparin

Item

Low molecular weight heparin (prophylactic)? (PTT < 60s; Anti-Xa < 0,6; INR < 2)

boolean

C0019139 (UMLS CUI [1])

Systemic heparin

Item

Systemic heparin (prophylactic)?

boolean

C0019134 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])

Laboratory Parameters and Blood Gas Analysis

Item Group

Laboratory Parameters and Blood Gas Analysis (24h before randomisation)

C0587081 (UMLS CUI-1)
C0005800 (UMLS CUI-2)

Arterial pCO2: Minimum

Item

Arterial pCO2: Minimum (BGA with max. FiO2) (possible units: kPa or mmHg)

float

C0428190 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Arterial pCO2: Maximum

Item

Arterial pCO2: Maximum (BGA with max. FiO2) (possible units: kPa or mmHg)

float

C0428190 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Arterial pCO2: Unit

Item

Arterial pCO2: possible units:

text

C0428190 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Arterial pCO2: Unit

Code List

Arterial pCO2: possible units:

CL Item

kPa (kPa )

CL Item

mmHg (mmHg)

Arterial pO2: Minimum

Item

Arterial pCO2: Minimum (BGA with max. FiO2) (possible units: kPa or mmHg)

float

C0202155 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Arterial pO2: Maximum

Item

Arterial pO2: Maximum (BGA with max. FiO2) (possible units: kPa or mmHg)

float

C0202155 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Arterial pO2: Unit

Item

Arterial pO2: possible units:

text

C0202155 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Arterial pO2: Unit

Code List

Arterial pO2: possible units:

CL Item

kPa (kPa )

CL Item

mmHg (mmHg)

Fraction of inspired oxygen: Minimum

Item

Fraction of inspired oxygen: Minimum (for not ventilated patients (invasive + non-invasive): 21% (0,21))

float

C0428167 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Fraction of inspired oxygen: Maximum

Item

Fraction of inspired oxygen: Maximum (for not ventilated patients (invasive + non-invasive): 21% (0,21))

float

C0428167 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Arterial pH: Minimum

Item

Arterial pH: Minimum

float

C0428199 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Arterial pH: Maximum

Item

Arterial pH: Maximum

float

C0428199 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Base Excess: Minimum

Item

Base Excess: Minimum (measured in arterial blood)

float

C0201985 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Base Excess: Maximum

Item

Base Excess: Maximum (measured in arterial blood)

float

C0201985 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Bicarbonate: Minimum

Item

Bicarbonate: Minimum

float

C0202059 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Bicarbonate: Maximum

Item

Bicarbonate: Maximum

float

C0202059 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Potassium: Minimum

Item

Potassium: Minimum (possible units: mg/dL or mmol/L)

float

C0202194 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Potassium: Maximum

Item

Potassium: Maximum (possible units: mg/dL or mmol/L)

float

C0202194 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Potassium: Unit

Item

Potassium: possible units:

text

C0202194 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Potassium: Unit

Code List

Potassium: possible units:

CL Item

mg/dL (mg/dL )

CL Item

mmol/L (mmol/L)

Sodium: Minimum

Item

Sodium: Minimum (possible units: mg/dL or mmol/L)

float

C0337443 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Sodium: Maximum

Item

Sodium: Maximum (possible units: mg/dL or mmol/L)

float

C0337443 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Sodium: Unit

Item

Sodium: possible units:

text

C0337443 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Sodium: Unit

Code List

Sodium: possible units:

CL Item

mg/dL (mg/dL )

CL Item

mmol/L) (mmol/L))

Lactate: Maximum

Item

Lactate: Maximum (possible units: mg/dL or mmol/L)

float

C0428446 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Lactate: Unit

Item

Lactate: Maximum possible units:

text

C0428446 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Lactate: Unit

Code List

Lactate: Maximum possible units:

CL Item

mg/dL (mg/dL )

CL Item

mmol/L (mmol/L)

Serum Creatinine: Minimum

Item

Serum Creatinine: Minimum (possible units: mg/dL or μmol/L)

float

C0201976 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Serum Creatinine: Maximum

Item

Serum Creatinine: Maximum (possible units: mg/dL or μmol/L)

float

C0201976 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Serum Creatinine: Unit

Item

Serum Creatinine: possible units:

text

C0201976 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Serum Creatinine: Unit

Code List

Serum Creatinine: possible units:

CL Item

mg/dL (mg/dL )

CL Item

μmol/L (μmol/L)

Glomerular Filtration Rate

Item

Glomerular Filtration Rate (Please use Cockcroft-Gault-Formular)

float

C0017654 (UMLS CUI [1])

Urea: Maximum

Item

Urea: Maximum (possible units: mmol/L or mg/dL or μmol/L)

float

C0523961 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Urea: Unit

Item

Urea: possible units:

text

C0523961 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Urea: Unit

Code List

Urea: possible units:

CL Item

mmol/L (mmol/L )

CL Item

mg/dL (mg/dL )

CL Item

μmol/L (μmol/L)

Urea: specification

Item

Urea: specification

text

C0523961 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])

Urea: specification

Code List

Urea: specification

CL Item

Urea (Urea)

CL Item

Urea nitrogen (Urea nitrogen)

Leukocytes: Minimum

Item

Leukocytes: Minimum (possible units: G/I or 1/nL or 1000/μL=G/I or 1/nL or 1000/μL OR 1/μL=1/μL)

float

C0023508 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Leukocytes: Maximum

Item

Leukocytes: Maximum (possible units: G/I or 1/nL or 1000/μL=G/I or 1/nL or 1000/μL OR 1/μL=1/μL)

float

C0023508 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Leukocytes: Unit

Item

Leukocytes: possible units:

text

C0023508 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Leukocytes: Unit

Code List

Leukocytes: possible units:

CL Item

G/I or 1/nL or 1000/μL (G/I or 1/nL or 1000/μL)

CL Item

1/μL (1/μL)

Thrombocytes: Minimum

Item

Thrombocytes: Minimum (possible units: G/I or 1/nL or 1000/μL=G/I or 1/nL or 1000/μL OR 1/μL=1/μL)

float

C0032181 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Thrombocytes: Maximum

Item

Thrombocytes: Maximum (possible units: G/I or 1/nL or 1000/μL=G/I or 1/nL or 1000/μL OR 1/μL=1/μL)

float

C0032181 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Thrombocytes: Unit

Item

Thrombocytes: possible units:

text

C0032181 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Leukocytes: Unit

Code List

Thrombocytes: possible units:

CL Item

G/I or 1/nL or 1000/μL (G/I or 1/nL or 1000/μL)

CL Item

1/μL (1/μL)

Haemoglobin: Minimum

Item

Haemoglobin: Minimum (possible units: mmol/L or g/dL)

float

C0518015 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Haemoglobin: Maximum

Item

Haemoglobin: Maximum (possible units: mmol/L or g/dL)

float

C0518015 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Haemoglobin: Unit

Item

Haemoglobin: possible units:

text

C0518015 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Haemoglobin: Unit

Code List

Haemoglobin: possible units:

CL Item

mmol/L (mmol/L )

CL Item

g/dL (g/dL)

Haematocrit: Minimum

Item

Haematocrit: Minimum (possible units: % or I/L)

float

C0018935 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Haematocrit: Maximum

Item

Haematocrit: Maximum (possible units: % or I/L))

float

C0518015 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Haematocrit: Unit

Item

Haematocrit: possible units:

text

C0518015 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Haematocrit: Unit

Code List

Haematocrit: possible units:

CL Item

% (% )

CL Item

I/L (I/L)

PTT: Minimum

Item

PTT: Minimum

float

C0030605 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

PTT: Maximum

Item

PTT: Maximum

float

C0030605 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

INR: Minimum

Item

INR: Minimum

float

C0525032 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

INR: Maximum

Item

INR: Maximum

float

C0525032 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

CRP: Maximum

Item

CRP: Maximum (possible units: mg/L or mg/dL)

float

C0201657 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

CRP: Unit

Item

CRP: possible units:

text

C0201657 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

CRP: Unit

Code List

CRP: possible units:

CL Item

mg/L (mg/L )

CL Item

mg/dL (mg/dL)

CRP: Description

Item

CRP: Description:

text

C0201657 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])

CRP: Unit

Code List

CRP: Description:

CL Item

value with < described (value with < described)

CL Item

value with > described (value with > described)

Albumin: Minimum

Item

Albumin: Minimum (possible units: g/L or g/dL)

float

C0201838 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Albumin: Unit

Item

Albumin: possible units:

text

C0201838 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Albumin: Unit

Code List

Albumin: possible units:

CL Item

g/L (g/L )

CL Item

g/dL (g/dL)

Blood glucose: Minimum

Item

Blood glucose: Minimum (possible units: mg/dL or mmol/L)

float

C0202042 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Blood glucose: Maximum

Item

Blood glucose: Maximum (possible units: mg/dL or mmol/L)

float

C0202042 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Blood glucose: Unit

Item

Blood glucose: possible units:

text

C0202042 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Blood glucose: Unit

Code List

Blood glucose: possible units:

CL Item

mg/dL (mg/dL)

CL Item

mmol/L (mmol/L)

Bilirubin: Maximum

Item

Bilirubin: Maximum (possible units: μmol/L or mg/dL)

float

C1278039 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Bilirubin: Unit

Item

Bilirubin: possible units:

text

C1278039 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Bilirubin: Unit

Code List

Bilirubin: possible units:

CL Item

μmol/L (μmol/L)

CL Item

mg/dL (mg/dL)

Phosphate: Minimum

Item

Phosphate: Minimum (possible units: mg/dL or mmol/L)

float

C0523826 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Phosphate: Maximum

Item

Phosphate: Maximum (possible units: mg/dL or mmol/L)

float

C0523826 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Phosphate: Unit

Item

Phosphate: possible units:

text

C0523826 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Phosphate: Unit

Code List

Phosphate: possible units:

CL Item

mg/dL (mg/dL )

CL Item

mmol/L (mmol/L)

Magnesium: Minimum

Item

Magnesium: Minimum (possible units: mg/dL or mmol/L)

float

C0373675 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Magnesium: Maximum

Item

Magnesium: Maximum (possible units: mg/dL or mmol/L)

float

C0373675 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Magnesium: Unit

Item

Magnesium: possible units:

text

C0373675 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Phosphate: Unit

Code List

Magnesium: possible units:

CL Item

mg/dL (mg/dL )

CL Item

mmol/L (mmol/L)

Chloride: Minimum

Item

Chloride: Minimum (possible units: mmol/L, mEq/L or mg/dL or g/L)

float

C0201952 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Chloride: Maximum

Item

Chloride: Maximum (possible units: mmol/L, mEq/L or mg/dL or g/L)

float

C0201952 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Chloride: Unit

Item

Chloride: possible units:

text

C0201952 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Chloride: Unit

Code List

Chloride: possible units:

CL Item

mmol/L, mEq/L (mmol/L, mEq/L )

CL Item

mg/dL (mg/dL)

CL Item

g/L (g/L)

Procalcitonin

Item

Procalcitonin

float

C1535922 (UMLS CUI [1])

Procalcitonin: Description

Item

Procalcitonin: Description:

text

C1535922 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])

CRP: Unit

Code List

Procalcitonin: Description:

CL Item

value with < described (value with < described)

CL Item

value with > described (value with > described)

Ionized Calcium: Miniumum

Item

Ionized Calcium: Miniumum

float

C0201927 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Ionized Calcium: Maximum

Item

Ionized Calcium: Maximum

float

C0201927 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Total Calcium: Miniumum

Item

Total Calcium: Miniumum

float

C0201925 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

Total Calcium: Maximum

Item

Total Calcium: Maximum

float

C0201925 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])

Fluid balance

Item Group

Fluid balance (from admission to ICU until randomisation)

C0016284 (UMLS CUI-1)

Fluid intake

Item

Fluid intake (cumulative) (among others: i.v. infusions, thrombocyte concentrates, erythrocyte concentrates, fresh plasma and enteral nutrition)

float

C0429791 (UMLS CUI [1])

Fluid output

Item

Fluid output (cumulative) (among others: faeces, urin, dialysat, vomiting, drainage and blood loss. Caution: irrigations are excluded)

float

C3251815 (UMLS CUI [1])

Urinary excretion

Item

Urinary excretion

float

C0042034 (UMLS CUI [1])

Urinary excretion: duration

Item

Urinary excretion duration

float

C0042034 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])

Transfusion

Item Group

Transfusion (from admission to ICU until randomisation)

C1879316 (UMLS CUI-1)

Blood loss

Item

Blood loss

float

C3163616 (UMLS CUI [1])

Erythrocyte concentrate

Item

Erythrocyte concentrate

float

C0086252 (UMLS CUI [1])

Fresh Frozen Plasma

Item

Fresh Frozen Plasma (FFP)

float

C0016709 (UMLS CUI [1])

Platelet concentrate

Item

Platelet concentrate

float

C1293886 (UMLS CUI [1])

Cell saver

Item

Cell saver

float

C1441512 (UMLS CUI [1])

Microbiology

Item Group

Microbiology (at screeing)

C0025952 (UMLS CUI-1)

Infection proven by microbiology

Item

Infection proven by microbiology?

boolean

C0009450 (UMLS CUI [1,1])
C0025952 (UMLS CUI [1,2])

Gram-positive bacteria

Item

Gram-positive bacteria?

boolean

C0018154 (UMLS CUI [1])

Gram-negative bacteria

Item

Gram-negative bacteria?

boolean

C0018150 (UMLS CUI [1])

Multiresitant bacteria

Item

Multiresitant bacteria

boolean

C4076168 (UMLS CUI [1])

Fungi

Item

Fungi

boolean

C0016832 (UMLS CUI [1])

Virus

Item

Virus

boolean

C0042776 (UMLS CUI [1])

Blood culture

Item

Test material: Blood culture

boolean

C0200949 (UMLS CUI [1])

Tracheal secretion

Item

Test material: Tracheal secretion

boolean

C0509485 (UMLS CUI [1])

Urine

Item

Test material: Urine

boolean

C0042036 (UMLS CUI [1])

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Comentarios del modelo :

Comentarios de grupo de elementos para :

Comentarios del elemento para :

Baseline RICH study NCT02669589

Baseline RICH study NCT02669589

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