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

NCT ID: NCT06259266

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-01-31

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 Unpublished preliminary data suggest that these valves allow parallel use of interdialytic saline locks without increasing the risk of dysfunction.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 .

Conditions

Chronic Renal Failure; Haemodialysis, Haemodiafiltration, Haemofiltration; Kidney Replacement Therapy; Catheter Infection, Catheter Dysfunction, Catheter Related Bloodstream Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

valce arm

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 ).

Group Type: EXPERIMENTAL

Anti-reflux valve for dialysis catheter

Intervention Type: OTHER

control arm

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 ).

Group Type: OTHER

Anti-reflux valve for dialysis catheter

Intervention Type: OTHER

Interventions

Anti-reflux valve for dialysis catheter

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Haemodialysis patients

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratoire HEMOTECH

UNKNOWN

Sponsor Role: collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne-Elisabeth HENG

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU de CERMONT-Ferrand

Clermont-Ferrand, , France

Countries

France

Other Identifiers

2012-A00530-43

Identifier Type: -

Identifier Source: secondary_id

CHU-0171

Identifier Type: -

Identifier Source: org_study_id