ID

15702

Description

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

Keywords

Versions (1)
  1. 6/8/16 6/8/16 -
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June 8, 2016

DOI

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Creative Commons BY-NC-ND 3.0
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    Randomization RICH study NCT02669589

    English

    Randomization RICH study NCT02669589

    1 forms  
    Patient Information
    Description

    Patient Information

    Alias
    UMLS CUI-1
    C1955348
    ID of Center
    Description

    Center ID

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    ID of patient
    Description

    Patient ID

    Data type

    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))
    Description

    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)
    Description

    Critical ill patients with acute kidney injury

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0010340
    UMLS CUI [1,2]
    C0022660
    2) Clinical indication for Renal Replacement Therapy?
    Description

    Clinical indication for Renal Replacement Therapy

    Data type

    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)
    Description

    Informed Consent

    Data type

    boolean

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

    Cardiovascular score

    Data type

    float

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

    Urine amount

    Data type

    text

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

    Gender

    Data type

    text

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

    Intensive Care duration

    Data type

    boolean

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

    Age

    Data type

    boolean

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

    Severe Sepsis or septic shock

    Data type

    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
    Description

    Catecholamine therapy

    Data type

    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)
    Description

    Lung oedema

    Data type

    text

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

    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?
    Description

    Exclusion Criteria at Randomization

    Data type

    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)
    Description

    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:
    Description

    Randomization result

    Data type

    text

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

    Randomization RICH study NCT02669589

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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