ID

15701

Beskrivning

NCT02669589 EudraCT-Nr. 2014-004854-33 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

Nyckelord

Versioner (1)
  1. 2016-06-08 2016-06-08 -
Uppladdad den

8 juni 2016

DOI

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Creative Commons BY-NC-ND 3.0
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Eligibilitiy Criteria RICH Study NCT02669589

Engelsk

Eligibilitiy Criteria RICH Study NCT02669589

1 Formulär  
Patient Information
Beskrivning

Patient Information

Alias
UMLS CUI-1
C1955348
ID of Center
Beskrivning

Center ID

Datatyp

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
ID of Patient
Beskrivning

Patient ID

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Start Date of Screening
Beskrivning

Screening Start Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0220908
Start timem of Screening
Beskrivning

Screening Start time

Datatyp

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0220908
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Patients who are critical ill with acute kidney injury (KDIGO Stadium 3)
Beskrivning

Critical ill patients with acute kidney injury

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0010340
UMLS CUI [1,2]
C0022660
Urinary excretion: < 0,3mL/kg/h for ≥ 24h (measured or estimated)
Beskrivning

Urinary excretion measurement

Datatyp

text

Alias
UMLS CUI [1]
C1285928
Serum Creatinine three times higher than baseline (baseline value of the last 7 days. If there is no baseline value, estimate value as described in WI (see also tables of KDIGO)
Beskrivning

Creatinine measurement

Datatyp

text

Alias
UMLS CUI [1]
C0201975
Serum creatine ≥ 4,0 mg/dL with acute increase around ≥ 0,5 mg/dL
Beskrivning

Creatinine measurement specification

Datatyp

text

Alias
UMLS CUI [1,1]
C0201975
UMLS CUI [1,2]
C2348235
Clinical Indication for Renal Replacement Therapy: Serum Urea > 150 mg/dL
Beskrivning

Urea measurement

Datatyp

text

Alias
UMLS CUI [1]
C0523961
Clinical indication for Renal Replacement Therapy: Potassium > 6 mmol/L
Beskrivning

Potassium measurement

Datatyp

text

Alias
UMLS CUI [1]
C0202194
Clinical Indication for Renal Replacement Therapy: Magnesium > 4 mmol/L and anuria
Beskrivning

Magnesium measurement and anuria

Datatyp

text

Alias
UMLS CUI [1]
C0373675
UMLS CUI [2]
C0003460
Clinical Indication for Renal Replacement Therapy: Blood pH < 7.15
Beskrivning

Blood pH measurement

Datatyp

text

Alias
UMLS CUI [1]
C0236489
Clinical indication for Renal Replacement Therapy: Urinary excretion < 200 mL/12h or Anuria
Beskrivning

Urinary excretion measurement or anuria

Datatyp

text

Alias
UMLS CUI [1]
C1285928
UMLS CUI [2]
C0003460
Clinical indication for Renal Replacement Therapy: Oedema in organs resistant to diuretics
Beskrivning

Oedema in organs resistant to diuretics

Datatyp

text

Alias
UMLS CUI [1,1]
C0013604
UMLS CUI [1,2]
C0332325
UMLS CUI [1,3]
C0013604
Written informed consent
Beskrivning

Written informed consent

Alias
UMLS CUI-1
C0021430
Written informed consent?
Beskrivning

Written informed consent

Datatyp

text

Alias
UMLS CUI [1]
C0021430
Date of informed consent
Beskrivning

Date of informed consent

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021430
Time of informed consent
Beskrivning

Time of informed consent

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0021430
If clinical indication, possibility to start treatment immediately or within 24 hours after achieving KDIGO stadium 3 after randomization?
Beskrivning

Therapy start

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0439659
Exclusion Criteria - if one or more of the criteria is correct, exclude the patient
Beskrivning

Exclusion Criteria - if one or more of the criteria is correct, exclude the patient

Alias
UMLS CUI-1
C0680251
Any increased bleeding risks? (e.g. active bleeding from ulceration of gastrointestinal tract, Hypertension with diastolic pressure > 105 mmHg, injuries of the brain (intracranial bleeding, brain artery aneurysms), or CNS operations which cannot achieve target PTT 45 - 60 sec, severe retinopathies, vitreous body bleeding, ophthalmic operations or injuries, active tuberculosis, infectious endocarditis)
Beskrivning

Bleeding risk

Datatyp

boolean

Alias
UMLS CUI [1]
C3251812
Any disorders and organ damages which are connected to haemorrhagic diathesis? (Coagulopathies, thrombocytopenia, severe diseases of liver and pancreas)
Beskrivning

Haemorrhagic diathesis

Datatyp

boolean

Alias
UMLS CUI [1]
C0019087
Any Chronic Kidney Disease (KDOQI IV without requiring dialysis (GFR< 30 ml/min calculated on Cockroft-Gault-formular))?
Beskrivning

Chronic Kidney Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C1561643
Acute Kidney Injury requiring dialysis during the last 90 days?
Beskrivning

Acute Kidney Injury requiring dialysis

Datatyp

boolean

Alias
UMLS CUI [1]
C2609414
UMLS CUI [2]
C0011946
Chronic kidney failure requiring dialysis?
Beskrivning

Chronic kidney failure requiring dialysis

Datatyp

boolean

Alias
UMLS CUI [1]
C0748304
Systemic anticoagulation therapy? (Effective anticoagulation: PTT > 60s, Anti-Xa > 0,6 IE/mL, INR > 2)
Beskrivning

Anticoagluation therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0003281
Any Hypersensitivity to one of the anticoagulants or heparin-induced thrombocytopenia
Beskrivning

Hypersensitivity to anticoagulants or HIT

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0003280
UMLS CUI [2]
C0272285
Acute Kidney Injury due to renal artery occlusion or surgical lesion of renal artery?
Beskrivning

Acute Kidney Injury due to renal artery occlusion or surgical lesion of renal artery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0553718
UMLS CUI [1,2]
C2609414
UMLS CUI [2,1]
C0282208
UMLS CUI [2,2]
C0035065
Acute Kidney Injury due to (glomerulo-) nephritis, interstital nephritis, vasculitis, postrenal obstruction?
Beskrivning

Acute Kidney Injury

Datatyp

boolean

Alias
UMLS CUI [1]
C2609414
DNR-order?
Beskrivning

DNR-Order

Datatyp

boolean

Alias
UMLS CUI [1]
C0582114
Haemolytic uremic syndrome and/or thrombotic thrombocytopenic purpura?
Beskrivning

Haemolytic uremic syndrome or thrombotic thrombocytopenic purpura

Datatyp

boolean

Alias
UMLS CUI [1]
C0019061
UMLS CUI [2]
C0034155
Persisting and severe lactate acidosis (pH < 7.2 in two measurments for > 2h; lactate > 8 mmol/L) in the context of acute liver failure or shock?
Beskrivning

Lactate acidosis

Datatyp

boolean

Alias
UMLS CUI [1]
C4039171
Kidney transplantation in the last 12 months?
Beskrivning

Kidney transplantation

Datatyp

boolean

Alias
UMLS CUI [1]
C0022671
Positive pregnancy test in women of childbearing age or breast feeding?
Beskrivning

Pregnancy test or breast feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032976
UMLS CUI [2]
C0006147
Abortus imminens?
Beskrivning

Abortus imminens

Datatyp

boolean

Alias
UMLS CUI [1]
C0948664
No access to free continous dialysis machines at time of inclusion?
Beskrivning

Access to dialysis machines

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3489407
UMLS CUI [1,2]
C0444454
Participation in other intervention studies in the last 3 months?
Beskrivning

Study participation status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
Any personal relations to person who is responsible for study conduct?
Beskrivning

Relation to study doctor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0869014
UMLS CUI [1,2]
C0031831
Living in an institution due to legal or official order?
Beskrivning

Living Arrangement - Institution

Datatyp

boolean

Alias
UMLS CUI [1]
C1546848
Identification and Signature
Beskrivning

Identification and Signature

Alias
UMLS CUI-1
C0205396
UMLS CUI-2
C1519316
Date of report (inclusion and exclusion criteria)
Beskrivning

Date of report

Datatyp

date

Alias
UMLS CUI [1]
C1302584
Time of report (inclusion and exclusion criteria)
Beskrivning

Time of report

Datatyp

time

Alias
UMLS CUI [1]
C1549507
Name of authorised physician
Beskrivning

Doctor's name

Datatyp

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C0031831
Signature of physician
Beskrivning

Doctor's signature

Datatyp

text

Alias
UMLS CUI [1]
C1519316
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Similar models

Eligibilitiy Criteria RICH Study NCT02669589

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
Screening Start Date
Item
Start Date of Screening
date
C0808070 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
Screening Start time
Item
Start timem of Screening
time
C1301880 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Critical ill patients with acute kidney injury
Item
Patients who are critical ill with acute kidney injury (KDIGO Stadium 3)
boolean
C0010340 (UMLS CUI [1,1])
C0022660 (UMLS CUI [1,2])
Item
Urinary excretion: < 0,3mL/kg/h for ≥ 24h (measured or estimated)
text
C1285928 (UMLS CUI [1])
Urinary excretion
Code List
Urinary excretion: < 0,3mL/kg/h for ≥ 24h (measured or estimated)
CL Item
yes (yes)
CL Item
no (no)
CL Item
unknown (unknown)
Item
Serum Creatinine three times higher than baseline (baseline value of the last 7 days. If there is no baseline value, estimate value as described in WI (see also tables of KDIGO)
text
C0201975 (UMLS CUI [1])
Creatinine measurement
Code List
Serum Creatinine three times higher than baseline (baseline value of the last 7 days. If there is no baseline value, estimate value as described in WI (see also tables of KDIGO)
CL Item
yes (yes)
CL Item
no (no)
CL Item
unknown (unknown)
Item
Serum creatine ≥ 4,0 mg/dL with acute increase around ≥ 0,5 mg/dL
text
C0201975 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Creatinine measurement specification
Code List
Serum creatine ≥ 4,0 mg/dL with acute increase around ≥ 0,5 mg/dL
CL Item
yes  (yes )
CL Item
no (no)
CL Item
unknown (unknown)
Item
Clinical Indication for Renal Replacement Therapy: Serum Urea > 150 mg/dL
text
C0523961 (UMLS CUI [1])
Urea measurement
Code List
Clinical Indication for Renal Replacement Therapy: Serum Urea > 150 mg/dL
CL Item
yes (yes)
CL Item
no (no)
CL Item
unknown (unknown)
Item
Clinical indication for Renal Replacement Therapy: Potassium > 6 mmol/L
text
C0202194 (UMLS CUI [1])
Potassium measurement
Code List
Clinical indication for Renal Replacement Therapy: Potassium > 6 mmol/L
CL Item
yes (yes)
CL Item
no (no)
CL Item
unknown (unknown)
Item
Clinical Indication for Renal Replacement Therapy: Magnesium > 4 mmol/L and anuria
text
C0373675 (UMLS CUI [1])
C0003460 (UMLS CUI [2])
Magnesium measurement and anuria
Code List
Clinical Indication for Renal Replacement Therapy: Magnesium > 4 mmol/L and anuria
CL Item
yes (yes)
CL Item
no (no)
CL Item
unknown (unknown)
Item
Clinical Indication for Renal Replacement Therapy: Blood pH < 7.15
text
C0236489 (UMLS CUI [1])
Blood pH measurement
Code List
Clinical Indication for Renal Replacement Therapy: Blood pH < 7.15
CL Item
yes (yes)
CL Item
no (no)
CL Item
unknown (unknown)
Item
Clinical indication for Renal Replacement Therapy: Urinary excretion < 200 mL/12h or Anuria
text
C1285928 (UMLS CUI [1])
C0003460 (UMLS CUI [2])
Urinary excretion measurement or anuria
Code List
Clinical indication for Renal Replacement Therapy: Urinary excretion < 200 mL/12h or Anuria
CL Item
yes (yes)
CL Item
no (no)
CL Item
unknown (unknown)
Item
Clinical indication for Renal Replacement Therapy: Oedema in organs resistant to diuretics
text
C0013604 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
C0013604 (UMLS CUI [1,3])
Oedema in organs resistant to diuretics
Code List
Clinical indication for Renal Replacement Therapy: Oedema in organs resistant to diuretics
CL Item
yes (yes)
CL Item
no (no)
CL Item
unknown (unknown)
Item Group
Written informed consent
C0021430 (UMLS CUI-1)
Item
Written informed consent?
text
C0021430 (UMLS CUI [1])
Written informed consent
Code List
Written informed consent?
CL Item
yes, given by patient (yes, given by patient)
CL Item
yes, given by legal representative --> seek informed consent given by patient subsequently (yes, given by legal representative --> seek informed consent given by patient subsequently)
CL Item
no, but emergency situation (confirmation by consular doctor) --> if necessary supervisory relationship or seek informed consent given by patient subsequently (no, but emergency situation (confirmation by consular doctor) --> if necessary supervisory relationship or seek informed consent given by patient subsequently)
CL Item
no, but confirmation by relatives --> seek informed consent given by patient subsequently (no, but confirmation by relatives --> seek informed consent given by patient subsequently)
Date of informed consent
Item
Date of informed consent
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Time of informed consent
Item
Time of informed consent
time
C0040223 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Therapy start
Item
If clinical indication, possibility to start treatment immediately or within 24 hours after achieving KDIGO stadium 3 after randomization?
boolean
C0087111 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
Item Group
Exclusion Criteria - if one or more of the criteria is correct, exclude the patient
C0680251 (UMLS CUI-1)
Bleeding risk
Item
Any increased bleeding risks? (e.g. active bleeding from ulceration of gastrointestinal tract, Hypertension with diastolic pressure > 105 mmHg, injuries of the brain (intracranial bleeding, brain artery aneurysms), or CNS operations which cannot achieve target PTT 45 - 60 sec, severe retinopathies, vitreous body bleeding, ophthalmic operations or injuries, active tuberculosis, infectious endocarditis)
boolean
C3251812 (UMLS CUI [1])
Haemorrhagic diathesis
Item
Any disorders and organ damages which are connected to haemorrhagic diathesis? (Coagulopathies, thrombocytopenia, severe diseases of liver and pancreas)
boolean
C0019087 (UMLS CUI [1])
Chronic Kidney Diseases
Item
Any Chronic Kidney Disease (KDOQI IV without requiring dialysis (GFR< 30 ml/min calculated on Cockroft-Gault-formular))?
boolean
C1561643 (UMLS CUI [1])
Acute Kidney Injury requiring dialysis
Item
Acute Kidney Injury requiring dialysis during the last 90 days?
boolean
C2609414 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
Chronic kidney failure requiring dialysis
Item
Chronic kidney failure requiring dialysis?
boolean
C0748304 (UMLS CUI [1])
Anticoagluation therapy
Item
Systemic anticoagulation therapy? (Effective anticoagulation: PTT > 60s, Anti-Xa > 0,6 IE/mL, INR > 2)
boolean
C0003281 (UMLS CUI [1])
Hypersensitivity to anticoagulants or HIT
Item
Any Hypersensitivity to one of the anticoagulants or heparin-induced thrombocytopenia
boolean
C0020517 (UMLS CUI [1,1])
C0003280 (UMLS CUI [1,2])
C0272285 (UMLS CUI [2])
Acute Kidney Injury due to renal artery occlusion or surgical lesion of renal artery
Item
Acute Kidney Injury due to renal artery occlusion or surgical lesion of renal artery?
boolean
C0553718 (UMLS CUI [1,1])
C2609414 (UMLS CUI [1,2])
C0282208 (UMLS CUI [2,1])
C0035065 (UMLS CUI [2,2])
Acute Kidney Injury
Item
Acute Kidney Injury due to (glomerulo-) nephritis, interstital nephritis, vasculitis, postrenal obstruction?
boolean
C2609414 (UMLS CUI [1])
DNR-Order
Item
DNR-order?
boolean
C0582114 (UMLS CUI [1])
Haemolytic uremic syndrome or thrombotic thrombocytopenic purpura
Item
Haemolytic uremic syndrome and/or thrombotic thrombocytopenic purpura?
boolean
C0019061 (UMLS CUI [1])
C0034155 (UMLS CUI [2])
Lactate acidosis
Item
Persisting and severe lactate acidosis (pH < 7.2 in two measurments for > 2h; lactate > 8 mmol/L) in the context of acute liver failure or shock?
boolean
C4039171 (UMLS CUI [1])
Kidney transplantation
Item
Kidney transplantation in the last 12 months?
boolean
C0022671 (UMLS CUI [1])
Pregnancy test or breast feeding
Item
Positive pregnancy test in women of childbearing age or breast feeding?
boolean
C0032976 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Abortus imminens
Item
Abortus imminens?
boolean
C0948664 (UMLS CUI [1])
Access to dialysis machines
Item
No access to free continous dialysis machines at time of inclusion?
boolean
C3489407 (UMLS CUI [1,1])
C0444454 (UMLS CUI [1,2])
Study participation status
Item
Participation in other intervention studies in the last 3 months?
boolean
C2348568 (UMLS CUI [1])
Relation to study doctor
Item
Any personal relations to person who is responsible for study conduct?
boolean
C0869014 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Living Arrangement - Institution
Item
Living in an institution due to legal or official order?
boolean
C1546848 (UMLS CUI [1])
Item Group
Identification and Signature
C0205396 (UMLS CUI-1)
C1519316 (UMLS CUI-2)
Date of report
Item
Date of report (inclusion and exclusion criteria)
date
C1302584 (UMLS CUI [1])
Time of report
Item
Time of report (inclusion and exclusion criteria)
time
C1549507 (UMLS CUI [1])
Doctor's name
Item
Name of authorised physician
text
C0027365 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Doctor's signature
Item
Signature of physician
text
C1519316 (UMLS CUI [1])
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