Catheter Dysfunction Rate in Patients Undergoing Kidney Replacement Therapy. Evaluation of the Safety and Efficacy of Anti-reflux Valves Without Heparin Lock Solution

Not Applicable

Withdrawn

• Conditions: Chronic Renal Failure; Catheter Infection, Catheter Dysfunction, Catheter Related Bloodstream Infections; Haemodialysis, Haemodiafiltration, Haemofiltration; Kidney Replacement Therapy
• Interventions: Other: Anti-reflux valve for dialysis catheter

• Registration Number: NCT06259266
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

Catheter dysfunction and infections are the most common complications observed among patients with dialysis catheters for long-term dialysis ( CDLD ) . They are causing a worsening of the morbidity and mortality of patients , loss of quality of renal replacement therapy , a reduction in the duration of catheterization , as well as increased spending related to health care.

The use of anti- reflux ( Tego ® , ICU Medical , USA, distributed by the Laboratory Hemotech , FRANCE ) valves reduces the rate of dysfunction and infections CDLD( catheters for long-term dialysis ). Unpublished preliminary data suggest that these valves allow parallel use of interdialytic saline locks without increasing the risk of dysfunction. This strategy would therefore achieve significant savings usual interdialytic CDLD( catheters for long-term dialysis )locks ( including heparin) whose use is not devoid of potentially serious adverse events and whose health care costs have increased dramatically in recent years . Moreover, this would also produce savings in fibrinolytic treatment.

A randomized controlled trial is needed to assess the effectiveness of TEGO ® valves in combination with saline locks on the risk of dysfunction CDLD(catheters for long-term dialysis ) .

Detailed Description

Interventional prospective, multicenter (8 dialysis units) , randomized, controlled, open study. Two strategies are compared in a parallel plan : a "valve arm " (implementation of TEGO ® valve associated with interdialytic saline locks) and a "control arm" ( standard care ). Rate of dialysis session with dysfunctions during the first six months of the study is the primary endpoint. It will be analyzed " per protocol ". The total duration of patient follow-up is 12 months.

After the first 6 months, patients in the "valve arm" retain the same type of care until the end of the study. The control patients continue to receive the usual concentrated heparin locks . The secondary endpoints of the study will be analyzed to 12 months. Training of health care teams is expected before the start of the study .

Study Timeline

• Status Verified: 2013-11
• Study First Submitted: 2013-11-26
• Study Start: 2013-12
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Study First Submitted QC: 2024-02-06
• Last Update Submitted: 2024-02-06
• Study First Posted: 2024-02-14
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Haemodialysis patients

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
valce arm	Anti-reflux valve for dialysis catheter	Two strategies are compared in a parallel plan : a "valve arm " (implementation of TEGO ® valve associated with interdialytic saline locks) and a "control arm" ( standard care ).
control arm	Anti-reflux valve for dialysis catheter	Two strategies are compared in a parallel plan : a "valve arm " (implementation of TEGO ® valve associated with interdialytic saline locks) and a "control arm" ( standard care ).

Primary Outcome Measures

Name	Time	Method
Rate of dialysis session with dysfunctions	during the first six months

Secondary Outcome Measures

Name	Time	Method
evaluation of the infectious complications associated with CDLD (catheters for long-term dialysis)	during the first six months

Trial Locations

Locations (1)

CHU de CERMONT-Ferrand; 🇫🇷 Clermont-Ferrand, France