Biological and Clinical Measurements Following Systemic Leakage When a Citrate or Heparin Lock is Used

Phase 4

Completed

• Conditions: Acute Renal Insufficiency
• Interventions: Drug: citrate 4%; Drug: unfractionated heparin; Biological: blood sample

• Registration Number: NCT02860299
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

In the VERROUREA study, there were two cases of an abnormal increase in TCA. In theory no leakage of the lock into the bloodstream should have been seen. Lock leakage could have particularly serious, and especially clinical, repercussions in these patients who already have a high risk of haemorrhage given the numerous associated comorbidities. The aim of this study is to investigate the leakage of locks into the bloodstream by measuring, before and after injection of the lock, the evolution of haemostasis tests and calcaemia. The findings will complete safety data already collected in the VERROU REA study.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2016-01
• Status Verified: 2016-07
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-08
• Last Update Submitted: 2016-08-08
• Study First Posted: 2016-08-09
• Last Update Posted: 2016-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• Patient aged > 18 years
• Requiring dialysis for acute kidney failure
• In whom a first non-tunnelled catheter has been inserted
• In the jugular or femoral position
• Once informed consent has been obtained from the patient, a family member or a person of trust

Exclusion Criteria

• Patients with active and poorly-controlled bleeding
• Known allergy to citrate
• Liver failure (Factor V <30%)
• Thrombopenia < 30 000/mm3 in the absence of planned corrective measures at the time of randomization
• Known or suspected heparin-induced thrombopenia
• Positive blood cultures without treatment or with inappropriate treatment at the time of randomization
• Catheter inserted in the subclavian position
• Person without national health insurance cover
• Pregnant women
• Adults under guardianship

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Citrate lock	citrate 4%	-
Citrate lock	blood sample	-
Heparin lock	blood sample	-
Heparin lock	unfractionated heparin	-

Primary Outcome Measures

Name	Time	Method
Level of calcaemia	through study completion an average of 28 days
Level of haemostasis	through study completion an average of 28 days

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France