Citrate Versus Heparin for the Lock of Non-tunneled Hemodialysis Catheters in Patients Hospitalised in ICU = Multicentre, Controlled, Randomised Superiority Trial
Overview
- Phase
- Phase 3
- Intervention
- unfractionated heparin
- Conditions
- Patients With Acute Renal Insufficiency
- Sponsor
- Centre Hospitalier Universitaire Dijon
- Enrollment
- 405
- Locations
- 1
- Primary Endpoint
- 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)
- Status
- Completed
- Last Updated
- 2 months ago
Overview
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…)
Investigators
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
Arms & Interventions
Heparin lock
Intervention: unfractionated heparin
Citrate lock
Intervention: Citrate 4%
Outcomes
Primary Outcomes
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