ID

15702

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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Randomization RICH study NCT02669589

Engelsk

Randomization 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
Inclusion Criteria at randomization (at least one of the first two (1. - 2.) questions has to be answered with "yes" and at least one of the last three criterias (I. - III.) must be fulfilled))
Beskrivning

Inclusion Criteria at randomization (at least one of the first two (1. - 2.) questions has to be answered with "yes" and at least one of the last three criterias (I. - III.) must be fulfilled))

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C0034656
1) 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
2) Clinical indication for Renal Replacement Therapy?
Beskrivning

Clinical indication for Renal Replacement Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0206074
Written informed consent? (given by patient or authorized representative or relative or carers or confirmation of emergency situation)
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Cardiovascular score (please record point value)
Beskrivning

Cardiovascular score

Datatyp

float

Alias
UMLS CUI [1,1]
C0007226
UMLS CUI [1,2]
C0449820
Urine amount
Beskrivning

Urine amount

Datatyp

text

Alias
UMLS CUI [1]
C1822256
Patient's gender
Beskrivning

Gender

Datatyp

text

Alias
UMLS CUI [1]
C0079399
Unlimited intesive care is planned at least for 3 days?
Beskrivning

Intensive Care duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085559
UMLS CUI [1,2]
C0449238
Age: 18 - 90 years old?
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
I. Severe sepsis or septic shock?
Beskrivning

Severe Sepsis or septic shock

Datatyp

text

Alias
UMLS CUI [1]
C1719672
UMLS CUI [2]
C0036983
II. Higher usage of catecholamine therapy? (Norepinephrine or Epinephrin ≥ 0,1 μg/kg/min OR Norepinephrine ≥ 0,05 μg/kg/min + Dobutamine each dose OR Norepinephrine ≥ 0,05 μg/kg/min + Vasopressin each dose OR Norepinephrine ≥ 0,05 μg/kg/min + Epinephrine ≥ 0,05 μg/kg/min
Beskrivning

Catecholamine therapy

Datatyp

text

Alias
UMLS CUI [1]
C0007412
III. Development or deterioration of lung oedema due to refractory fluid overload (PaO2/ FiO2 < 300 mmHg and/or fluid balance > 10% of starting body weight)
Beskrivning

Lung oedema

Datatyp

text

Alias
UMLS CUI [1]
C0034063
Exclusion Criteria at Randomization
Beskrivning

Exclusion Criteria at Randomization

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C0034656
If there is any exclusion Criteria at Randomization fulfilled, exclude the patient and do not randomize him/her. Is any of the exclusion Criteria positive?
Beskrivning

Exclusion Criteria at Randomization

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0034656
Randomization Groups - Randomization has to be done with help of www.sepnet.de. The result will be issued automatically and a fax with the confirmation of randomisation will be sent)
Beskrivning

Randomization Groups - Randomization has to be done with help of www.sepnet.de. The result will be issued automatically and a fax with the confirmation of randomisation will be sent)

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0441833
Result of Randomization:
Beskrivning

Randomization result

Datatyp

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0034656
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Similar models

Randomization 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])
Item Group
Inclusion Criteria at randomization (at least one of the first two (1. - 2.) questions has to be answered with "yes" and at least one of the last three criterias (I. - III.) must be fulfilled))
C1512693 (UMLS CUI-1)
C0034656 (UMLS CUI-2)
Critical ill patients with acute kidney injury
Item
1) Patients who are critical ill with acute kidney injury (KDIGO Stadium 3)
boolean
C0010340 (UMLS CUI [1,1])
C0022660 (UMLS CUI [1,2])
Clinical indication for Renal Replacement Therapy
Item
2) Clinical indication for Renal Replacement Therapy?
boolean
C0392360 (UMLS CUI [1,1])
C0206074 (UMLS CUI [1,2])
Informed Consent
Item
Written informed consent? (given by patient or authorized representative or relative or carers or confirmation of emergency situation)
boolean
C0021430 (UMLS CUI [1])
Cardiovascular score
Item
Cardiovascular score (please record point value)
float
C0007226 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Item
Urine amount
text
C1822256 (UMLS CUI [1])
Urine amount
Code List
Urine amount
CL Item
Oliguria (Oliguria)
CL Item
Normuria (Normuria)
Item
Patient's gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Patient's gender
CL Item
female (female)
CL Item
male (male)
Intensive Care duration
Item
Unlimited intesive care is planned at least for 3 days?
boolean
C0085559 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Age
Item
Age: 18 - 90 years old?
boolean
C0001779 (UMLS CUI [1])
Item
I. Severe sepsis or septic shock?
text
C1719672 (UMLS CUI [1])
C0036983 (UMLS CUI [2])
Severe Sepsis or septic shock
Code List
I. Severe sepsis or septic shock?
CL Item
yes (yes)
CL Item
no (no)
CL Item
unknown (unknown)
Item
II. Higher usage of catecholamine therapy? (Norepinephrine or Epinephrin ≥ 0,1 μg/kg/min OR Norepinephrine ≥ 0,05 μg/kg/min + Dobutamine each dose OR Norepinephrine ≥ 0,05 μg/kg/min + Vasopressin each dose OR Norepinephrine ≥ 0,05 μg/kg/min + Epinephrine ≥ 0,05 μg/kg/min
text
C0007412 (UMLS CUI [1])
Catecholamine therapy
Code List
II. Higher usage of catecholamine therapy? (Norepinephrine or Epinephrin ≥ 0,1 μg/kg/min OR Norepinephrine ≥ 0,05 μg/kg/min + Dobutamine each dose OR Norepinephrine ≥ 0,05 μg/kg/min + Vasopressin each dose OR Norepinephrine ≥ 0,05 μg/kg/min + Epinephrine ≥ 0,05 μg/kg/min
CL Item
yes (yes)
CL Item
no (no)
CL Item
unknown) (unknown))
Item
III. Development or deterioration of lung oedema due to refractory fluid overload (PaO2/ FiO2 < 300 mmHg and/or fluid balance > 10% of starting body weight)
text
C0034063 (UMLS CUI [1])
Lung oedema
Code List
III. Development or deterioration of lung oedema due to refractory fluid overload (PaO2/ FiO2 < 300 mmHg and/or fluid balance > 10% of starting body weight)
CL Item
yes (yes)
CL Item
no (no)
CL Item
unknown (unknown)
Item Group
Exclusion Criteria at Randomization
C0680251 (UMLS CUI-1)
C0034656 (UMLS CUI-2)
Exclusion Criteria at Randomization
Item
If there is any exclusion Criteria at Randomization fulfilled, exclude the patient and do not randomize him/her. Is any of the exclusion Criteria positive?
boolean
C0680251 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Item Group
Randomization Groups - Randomization has to be done with help of www.sepnet.de. The result will be issued automatically and a fax with the confirmation of randomisation will be sent)
C0034656 (UMLS CUI-1)
C0441833 (UMLS CUI-2)
Item
Result of Randomization:
text
C1274040 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Randomization result
Code List
Result of Randomization:
CL Item
Regional citrate group (Regional citrate group)
CL Item
Systemic heparin group (Systemic heparin group)
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