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ID

15701

Descrição

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

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Versões (1)
  1. 08/06/2016 08/06/2016 -
Transferido a

8 de junho de 2016

DOI

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

    Inglês

    Eligibilitiy Criteria RICH Study NCT02669589

    1 Formulários  
    Patient Information
    Descrição

    Patient Information

    Alias
    UMLS CUI-1
    C1955348
    ID of Center
    Descrição

    Center ID

    Tipo de dados

    text

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

    Patient ID

    Tipo de dados

    text

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

    Screening Start Date

    Tipo de dados

    date

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

    Screening Start time

    Tipo de dados

    time

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

    Inclusion Criteria

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

    Critical ill patients with acute kidney injury

    Tipo de dados

    boolean

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

    Urinary excretion measurement

    Tipo de dados

    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)
    Descrição

    Creatinine measurement

    Tipo de dados

    text

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

    Creatinine measurement specification

    Tipo de dados

    text

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

    Urea measurement

    Tipo de dados

    text

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

    Potassium measurement

    Tipo de dados

    text

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

    Magnesium measurement and anuria

    Tipo de dados

    text

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

    Blood pH measurement

    Tipo de dados

    text

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

    Urinary excretion measurement or anuria

    Tipo de dados

    text

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

    Oedema in organs resistant to diuretics

    Tipo de dados

    text

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

    Written informed consent

    Alias
    UMLS CUI-1
    C0021430
    Written informed consent?
    Descrição

    Written informed consent

    Tipo de dados

    text

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

    Date of informed consent

    Tipo de dados

    date

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

    Time of informed consent

    Tipo de dados

    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?
    Descrição

    Therapy start

    Tipo de dados

    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
    Descrição

    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)
    Descrição

    Bleeding risk

    Tipo de dados

    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)
    Descrição

    Haemorrhagic diathesis

    Tipo de dados

    boolean

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

    Chronic Kidney Diseases

    Tipo de dados

    boolean

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

    Acute Kidney Injury requiring dialysis

    Tipo de dados

    boolean

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

    Chronic kidney failure requiring dialysis

    Tipo de dados

    boolean

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

    Anticoagluation therapy

    Tipo de dados

    boolean

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

    Hypersensitivity to anticoagulants or HIT

    Tipo de dados

    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?
    Descrição

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

    Tipo de dados

    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?
    Descrição

    Acute Kidney Injury

    Tipo de dados

    boolean

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

    DNR-Order

    Tipo de dados

    boolean

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

    Haemolytic uremic syndrome or thrombotic thrombocytopenic purpura

    Tipo de dados

    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?
    Descrição

    Lactate acidosis

    Tipo de dados

    boolean

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

    Kidney transplantation

    Tipo de dados

    boolean

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

    Pregnancy test or breast feeding

    Tipo de dados

    boolean

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

    Abortus imminens

    Tipo de dados

    boolean

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

    Access to dialysis machines

    Tipo de dados

    boolean

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

    Study participation status

    Tipo de dados

    boolean

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

    Relation to study doctor

    Tipo de dados

    boolean

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

    Living Arrangement - Institution

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1546848
    Identification and Signature
    Descrição

    Identification and Signature

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

    Date of report

    Tipo de dados

    date

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

    Time of report

    Tipo de dados

    time

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

    Doctor's name

    Tipo de dados

    text

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

    Doctor's signature

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1519316
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    Eligibilitiy Criteria RICH Study NCT02669589

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    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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