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

Primary Purpose

Patients With Acute Renal Insufficiency

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Citrate 4%
unfractionated heparin
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Acute Renal Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Dijon

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Heparin lock

Citrate lock

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
August 27, 2013
Last Updated
August 14, 2018
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT01962116
Brief Title
Citrate Versus Heparin for the Lock of Non-tunneled Hemodialysis Catheters in Patients Hospitalised in ICU
Acronym
VERROU-REA
Official Title
Citrate Versus Heparin for the Lock of Non-tunneled Hemodialysis Catheters in Patients Hospitalised in ICU = Multicentre, Controlled, Randomised Superiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 14, 2013 (Actual)
Primary Completion Date
April 1, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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…)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Acute Renal Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
405 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heparin lock
Arm Type
Placebo Comparator
Arm Title
Citrate lock
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Citrate 4%
Intervention Type
Drug
Intervention Name(s)
unfractionated heparin
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU Dijon
City
Dijon
ZIP/Postal Code
21000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33314078
Citation
Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.
Results Reference
derived
PubMed Identifier
31264073
Citation
Quenot JP, Helms J, Bourredjem A, Dargent A, Meziani F, Badie J, Blasco G, Piton G, Capellier G, Mezher C, Rebibou JM, Nadji A, Crepin T, Barbar SD, Fleck C, Cransac A, Boulin M, Binquet C, Soudry-Faure A, Bruyere R; VERROU-REA Trial Investigators and the CRICS TRIGGERSEP Group (Clinical Research in Intensive Care and Sepsis Trial Group for Global Evaluation and Research in Sepsis). Trisodium citrate 4% versus heparin as a catheter lock for non-tunneled hemodialysis catheters in critically ill patients: a multicenter, randomized clinical trial. Ann Intensive Care. 2019 Jul 1;9(1):75. doi: 10.1186/s13613-019-0553-4.
Results Reference
derived
PubMed Identifier
25409678
Citation
Bruyere R, Soudry-Faure A, Capellier G, Binquet C, Nadji A, Torner S, Blasco G, Yannaraki M, Barbar SD, Quenot JP. Comparison of heparin to citrate as a catheter locking solution for non-tunneled central venous hemodialysis catheters in patients requiring renal replacement therapy for acute renal failure (VERROU-REA study): study protocol for a randomized controlled trial. Trials. 2014 Nov 19;15:449. doi: 10.1186/1745-6215-15-449.
Results Reference
derived

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

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