Citrate Versus Heparin for the Lock of Non-tunneled Hemodialysis Catheters in Patients Hospitalised in ICU (VERROU-REA)

August 14, 2018 updated by: Centre Hospitalier Universitaire Dijon

Citrate Versus Heparin for the Lock of Non-tunneled Hemodialysis Catheters in Patients Hospitalised in ICU = Multicentre, Controlled, Randomised Superiority Trial

After obtaining written informed consent and inclusion, patients will be randomised into 2 groups for the type of dialysis catheter lock:

  • The first group will have a citrate lock
  • The second group will have a heparin lock Patients will be stratified according to the centre and type of Renal Replacement Therapy (RRT) continuous or intermittent.

The daily surveillance of patients will not be different from the usual surveillance of patients on Renal Replacement Therapy.

The hemodialysis catheters used will be specific Renal Replacement Therapy catheters.

The decision to withdraw the catheter will be made by the investigator and based on clinical criteria (complications related to the catheter, termination of Renal Replacement Therapy…)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

405

Phase

  • Phase 3

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

  • France
      • Dijon, France, 21000
        • CHU Dijon

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:

  • Patients aged > 18 years
  • Requiring RRT for acute renal insufficiency
  • For which a 1st non-tunneled catheter is placed
  • In the jugular or femoral position
  • After written informed consent has been obtained from the patient, a member of the family or a person of trust

Exclusion Criteria:

  • Patient presenting active poorly controlled bleeding
  • Known allergy to citrate
  • Acute liver failure (Prothrombin level <30%)
  • Thrombopenia < 30 000/mm3
  • Known or suspected heparin-induced thrombopenia
  • Known systemic bacterial infection at the time the catheter is placed
  • catheter in the subclavicular position
  • Persons not affiliated to a national health insurance scheme
  • Pregnant women
  • Adults under guardianship

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Citrate lock
Drug: Citrate 4%
Placebo Comparator: Heparin lock
Drug: unfractionated heparin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of event-free survival of the first non-tunneled hemodialysis catheter (defined at the time in days from catheter insertion to withdrawal whatever the reason)
Time Frame: up to 28 days
up to 28 days

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 14, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

August 27, 2013

First Submitted That Met QC Criteria

October 10, 2013

First Posted (Estimate)

October 14, 2013

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QUENOT DB 2012

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.

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