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

Patients With Acute Renal Insufficiency Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01962116
• Other study ID #: QUENOT DB 2012
• Status: Completed
• Phase: Phase 3
• Start date: June 14, 2013
• Est. completion date: December 31, 2016

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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…)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: December 31, 2016
• Est. primary completion date: April 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Patients With Acute Renal Insufficiency
• Renal Insufficiency

Intervention

Drug:
• Citrate 4%

• unfractionated heparin

Locations

Country	Name	City	State
France	CHU Dijon	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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