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Trial record 53 of 111 for:    CALCIUM CATION

Investigating Different Anticoagulants for Renal Replacement Therapy (RICH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02669589
Recruitment Status : Active, not recruiting
First Posted : February 1, 2016
Last Update Posted : February 21, 2019
Sponsor:
Collaborators:
University of Leipzig
German Research Foundation
Information provided by (Responsible Party):
University Hospital Muenster

Brief Summary:
The aim of this study is to evaluate the effect of regional citrate anticoagulation within the scope of continuous renal replacement (CRRT) in critically ill patients with acute kidney injury (AKI) on filter life span and 90-day all cause mortality.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Drug: Heparin Drug: Citrate Phase 4

Detailed Description:

Purpose of clinical trial:

To evaluate the effect of regional citrate anticoagulation within the scope of continuous renal replacement (CRRT) in critically ill patients with acute kidney injury (AKI) on filter life span and 90-day all cause mortality.

Patient population: critically ill patients with acute kidney injury requiring renal replacement therapy.

Primary objective:

Anticoagulation of the extracorporeal circuit is required in continuous RRT (CRRT). To this date, it is not clear which anticoagulant should be used for CRRT. Regional citrate anticoagulation (RCA) for CRRT in critically ill patients with AKI prolongs filter life span and reduces 90-day all cause mortality by approximately 8% (from 48% to 40%) compared to systemic heparin anticoagulation for CRRT

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 638 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Regional Citrate Versus Systemic Heparin Anticoagulation for Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury
Actual Study Start Date : March 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: heparin anticoagulation

Systemic anticoagulation of the continuous renal replacement therapy with heparin.

Dose will be titrated to maintain aPTT (activated partial thromboplastin time) between 45-60s)

Drug: Heparin
Experimental: citrate anticoagulation

Regional anticoagulation of the continuous renal replacement therapy with citrate.

Target posthemofilter ionized calcium level: 0.25-0.35 mmol/l

Drug: Citrate



Primary Outcome Measures :
  1. CRRT-filter life span in hours [ Time Frame: during continuous renal replacement therapy up to 1 year ]
    It will be reported how long the filter will be used during CRRT

  2. Overall survival in a 90day follow-up period [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. ICU length of stay in days [ Time Frame: up to 1 year ]
    The primary ICU stay will be documented.

  2. Hospital length of stay in days [ Time Frame: up to 1 year ]
  3. duration of renal replacement therapy [ Time Frame: 1 year ]
    within 1 year after randomization

  4. Bleeding complication [ Time Frame: intraoperative ]
  5. Number of patients with administration of red blood cells [ Time Frame: intraoperative ]
  6. Rate of infection [ Time Frame: during primary ICU stay up to 1 year ]
  7. Major adverse kidney events [ Time Frame: day 28, 60, 90 and after 1 year after start of CRRT ]
  8. Complications of therapy [ Time Frame: intraoperative ]
  9. Recovery of renal function [ Time Frame: day 28, 60, 90 and 1 year after start of CRRT ]
    The recovery of renal function will be defined as composite endpoint consisting of lack of dialysis dependency and serum creatinine level no more than 0.5 mg/dl above the baseline value)

  10. Number of participants with hemodialysis [ Time Frame: day 28, 60, 90 and 1 year after start of CRRT ]
  11. Mortality [ Time Frame: day 28, 60 and 1-year ]

Other Outcome Measures:
  1. SOFA Scores (Sepsis-related Organ Failure Assessment score) [ Time Frame: day 1-14, 21 and 28 during ICU stay ]
  2. serum creatinine level in mg/dL [ Time Frame: Day 0, day 1, day 3, day 5 and 1 day after CRRT cessation ]
  3. plasma urea concentration in mg/dl [ Time Frame: Day 0, day 1, day 3, day 5 and 1 day after CRRT cessation ]
  4. glomerular filtration rate [ Time Frame: Day 0, day 1, day 3, day 5 and 1 day after CRRT cessation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Critically ill patients with clinical indication for CRRT (clinical decision to use continuous RRT due to hemodynamic instability)

    Or

    Severe acute kidney injury (KDIGO 3-classification) despite optimal resuscitation

  2. At least one of the following conditions

    • Sepsis or septic shock
    • Use of catecholamines (norepinephrine or epinephrine ≥ 0.1 µg/kg/min or norepinephrine ≥ 0.05 µg/kg/min + dobutamine (any dose) or norepinephrine ≥ 0.05 µg/kg/min + vasopressin (any dose) or epinephrine ≥ 0.05 µg/kg/min + norepinephrine ≥ 0.05 µg/kg/min)
    • Refractory fluid overload: worsening pulmonary edema: PaO2/FiO2 < 300 mmHg and/or fluid balance > 10% of body weight)
  3. 18-90 years old
  4. Intention to provide full intensive care treatment for at least 3 days
  5. Written informed consent of the patient or the legal representatives or the authorized representative or the inclusion due to an emergency situation

Exclusion Criteria:

  1. Patients with increased bleeding risk (e.g. an active bleeding from ulcers in the gastro-intestinal tract, hypertension with a diastolic blood pressure higher than 105 mm Hg, injuries (intracranial hemorrhage, aneurysm of brain arteries) of or surgical procedures on the central nervous system if a heparinization with a target aPTT 45-60 s is not allowed by the treating neurologist or neurosurgeon, severe retinopathies, bleeding into the vitreum, ophthalmic surgical procedures)) or injuries, active tuberculosis; infective endocarditis)
  2. Disease or organ damage related with hemorrhagic diathesis (coagulopathy, thrombocytopenia, severe liver or pancreas disease)
  3. Dialysis-dependent chronic kidney insufficiency
  4. Need of therapeutic systemic anticoagulation
  5. Allergic reaction to one of the anticoagulants or ingredients, Heparin-induced thrombocytopenia
  6. AKI caused by permanent occlusion or surgical lesion of the renal artery
  7. AKI caused by (glomerulo)nephritis, interstitial nephritis, vasculitis or postrenal obstruction
  8. Do-not-resuscitate order
  9. Hemolytic-uremic syndrome/thrombotic thrombocytopenic purpura
  10. Persistent and severe lactate acidosis in the context of an acute liver failure and/or shock
  11. Kidney transplant within the last 12 months
  12. Pregnancy and nursing period
  13. Abortus imminens
  14. No hemofiltration machine free for use at the moment of inclusion
  15. Participation in another clinical intervention trial in the last 3 months
  16. Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
  17. Persons held in an institution by legal or official order

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669589


Locations
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Sponsors and Collaborators
University Hospital Muenster
University of Leipzig
German Research Foundation
Investigators
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Study Chair: Alexander Zarbock, MD University Hospital Muenster

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT02669589    
Other Study ID Numbers: UKM 14_0066
2014-004854-33 ( EudraCT Number )
03-AnIt-14 ( Other Identifier: Dept. of Anesthesiology, Intensive Care and Pain Medicine )
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital Muenster:
CRRT
AKI
anticoagulation
KDIGO
Additional relevant MeSH terms:
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Calcium heparin
Calcium Chelating Agents
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Heparin
Citric Acid
Sodium Citrate
Anticoagulants
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents