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

Phase 3

Completed

• Conditions: Patients With Acute Renal Insufficiency
• Interventions: Drug: Citrate 4%; Drug: unfractionated heparin

• Registration Number: NCT01962116
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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...)

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-14
• Study First Submitted: 2013-08-27
• Study First Submitted QC: 2013-10-10
• Study First Posted: 2013-10-14
• Primary Completion: 2016-04-01
• Study Completion: 2016-12-31
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-14
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 405

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Citrate lock	Citrate 4%	-
Heparin lock	unfractionated heparin	-

Primary Outcome Measures

Name	Time	Method
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)	up to 28 days

Trial Locations

Locations (1)

CHU Dijon; 🇫🇷 Dijon, France