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Control Trial of Intermittent Hemodialysis With Regional Citrate VS Priming Heparin With Predilution in Patients at Risk of Bleeding (ROBIN)

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: NCT03562754
Recruitment Status : Completed
First Posted : June 19, 2018
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Study Description
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Brief Summary:
The study investigators hypothesize that intermittent hemodialysis with regional citrate anticoagulation (Prometheus system/Frésénius) is more efficient than reduced systemic heparin anticoagulation in patients at bleeding risk hospitalized in nephrology intensive care unit

Condition or disease Intervention/treatment Phase
Hemodialysis Procedure: reduced systemic heparin anticoagulation Procedure: Regional Citrate Anticoagulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Intermittent Hemodialysis With Regional Citrate Anticoagulation Versus Systemic Low Dose Heparin Anticoagulation in Patients at Risk of Bleeding in Nephrology Intensive Care Unit
Actual Study Start Date : March 11, 2019
Actual Primary Completion Date : November 11, 2020
Actual Study Completion Date : November 11, 2020

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control Procedure: reduced systemic heparin anticoagulation
receive intermittent hemodialysis (Frésenius 4008) with blood flow at least of (200 ml/min) with double vascular access, biocompatible membrane dialyzer, low dose non fractionated heparine (5000 UI initially) and predilution with 25 mls/min dialysate
Experimental: Prometheus System Procedure: Regional Citrate Anticoagulation
intermittent hemodialysis using Prometheus System with blood flow at least of 200 ml/min with double vascular access, biocompatible membrane dialyzer


Outcome Measures
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Primary Outcome Measures :
  1. Duration of intermittent hemodialysis between groups [ Time Frame: End of intermittent hemodialysis session (average 4 hours) ]
    Minutes


Secondary Outcome Measures :
  1. Hemodialysis treatment adequacy [ Time Frame: End of intermittent hemodialysis session (average 4 hours) ]
    KT/V value

  2. Transmembrane pressure between groups [ Time Frame: End of intermittent hemodialysis session (average 4 hours) ]
  3. Blood aspect in the extracorporeal treatment circuit [ Time Frame: End of intermittent hemodialysis session (average 4 hours) ]
    Clotting phenomena

  4. Occurrence of hemorrhage [ Time Frame: Hour 12 ]
    Yes/no

  5. Occurrence of metabolic disorders (hypocalcemia, metabolic alkalose) [ Time Frame: Hour 12 ]
    Yes/no

  6. Occurance of unexpected complications (almost none recorded in the literature) [ Time Frame: End of intermittent hemodialysis session (average 4 hours) ]
    Yes/no


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient has been correctly informed.
  • The patient must have given his/her informed and signed consent.
  • The legal guardian or trusted-person of an adult under guardianship must have given their informed and signed consent.
  • The patient has health insurance coverage via the French social security system.
  • The patient is at least 18 years old.
  • The patient is at bleeding risk; the bleeding risk is defined by the clinical situation and according to predefined clinical situations (before or after surgery or biopsy, hemorrhage).
  • The patient requires an intermittent hemodialysis in a nephrology ICU setting.

Exclusion Criteria:

  • The patient is participating in, or has participated in over the past three months, another interventional trial.
  • The patient is in an exclusion period determined by a previous study.
  • The patient is under judicial protection.
  • The parents (or legal guardian) of the patient refuse to sign the consent.
  • It is impossible to correctly inform the patient/parents (or legal guardian) of the patient (language barrier).
  • Contraindication to heparin treatment.
  • Indication of continuous dialysis in ICU.
  • Pregnancy.
Contacts and Locations
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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): NCT03562754


Locations
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France
CHU Nimes
Nîmes, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Olivier Moranne, MD CHU Nimes
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03562754    
Other Study ID Numbers: 2016/NIMAO2/OM-01
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Heparin
Anticoagulants
 Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents