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

January 15, 2021 updated by: Centre Hospitalier Universitaire de Nīmes

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

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

Study Overview

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Nîmes, France, 30029
        • CHU Nîmes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
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
intermittent hemodialysis using Prometheus System with blood flow at least of 200 ml/min with double vascular access, biocompatible membrane dialyzer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of intermittent hemodialysis between groups
Time Frame: End of intermittent hemodialysis session (average 4 hours)
Minutes
End of intermittent hemodialysis session (average 4 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodialysis treatment adequacy
Time Frame: End of intermittent hemodialysis session (average 4 hours)
KT/V value
End of intermittent hemodialysis session (average 4 hours)
Transmembrane pressure between groups
Time Frame: End of intermittent hemodialysis session (average 4 hours)
End of intermittent hemodialysis session (average 4 hours)
Blood aspect in the extracorporeal treatment circuit
Time Frame: End of intermittent hemodialysis session (average 4 hours)
Clotting phenomena
End of intermittent hemodialysis session (average 4 hours)
Occurrence of hemorrhage
Time Frame: Hour 12
Yes/no
Hour 12
Occurrence of metabolic disorders (hypocalcemia, metabolic alkalose)
Time Frame: Hour 12
Yes/no
Hour 12
Occurance of unexpected complications (almost none recorded in the literature)
Time Frame: End of intermittent hemodialysis session (average 4 hours)
Yes/no
End of intermittent hemodialysis session (average 4 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Olivier Moranne, MD, CHU Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2019

Primary Completion (Actual)

November 11, 2020

Study Completion (Actual)

November 11, 2020

Study Registration Dates

First Submitted

June 8, 2018

First Submitted That Met QC Criteria

June 8, 2018

First Posted (Actual)

June 19, 2018

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

November 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemodialysis

Clinical Trials on reduced systemic heparin anticoagulation

3
Subscribe