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

NCT06259266 | Withdrawn

• 2 other identifiers: CHU-01712012-A00530-43
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 Unpublished preliminary data suggest that these valves allow parallel use of interdialytic saline locks without increasing the risk of dysfunction.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

Conditions

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

Keywords

Catheter infection, catheter dysfunction, catheter related bloodstream infections,

Outcome Measures

Primary Outcomes (1)

• Rate of dialysis session with dysfunctions

  during the first six months

Secondary Outcomes (1)

• evaluation of the infectious complications associated with CDLD (catheters for long-term dialysis)

  during the first six months

Study Arms (2)

valce arm

EXPERIMENTAL

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 ).

Other: Anti-reflux valve for dialysis catheter

control arm

OTHER

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 ).

Other: Anti-reflux valve for dialysis catheter

Interventions

Anti-reflux valve for dialysis catheter OTHER

control arm; valce arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Haemodialysis patients

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Laboratoire HEMOTECH: collaborator

Study Sites (1)

CHU de CERMONT-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne-Elisabeth HENG

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: February 14, 2024
• Study Start: December 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 14, 2024

Record last verified: 2013-11

Locations

FR (1)