Antimicrobial Locks for Hemodialysis Catheter Infections

NCT07074821 | Completed Phase 2

• 1 other identifier: MoH/CSR/24/27480
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Tunneled hemodialysis catheters are susceptible to infection with high incidence of complication to the hemodialysis patients .The study aimed to prevent catheter infection through comparing use of antimicrobial solution (Taurolidine) when used as lock solution installed in the lumen of the catheter at the end of the hemodialysis session with the usually used lock solution heparin. The Study was performed on 100 hemodialysis patients over one year in Sohar hospital ,Oman .

Conditions

Catheter Related Blood Stream Infection; Hemodialysis; Vascular Access

Keywords

catheter related infection; hemodialysis; Taurolidine

Outcome Measures

Primary Outcomes (1)

• Comparison between both groups in terms of incidence of Catheter related blood stream infection

  The investigators have studied the incidence of catheter related bacterial infection in both groups to determine superior effectiveness of Taurolidine lock solution than Heparin lock only in terms of prevention of infection .

  one year

Secondary Outcomes (1)

• Comparison between both groups in terms of treatment cost

  one year

Study Arms (2)

Group (A) patients used usual Heparin used as tunneled hemodialysis lock solution

NO INTERVENTION

Measure incidence of catheter related blood stream infection while patients use Heparin as catheter lock

Group (B) patients used Taurolidine based lock solution as tunneled hemodialysis catheter lock

EXPERIMENTAL

Measure incidence of catheter related blood stream infection while patients use Taurolidine based lock solution as catheter lock

Drug: Taurolidine citrate 4% and heparin 500

Interventions

Taurolidine citrate 4% and heparin 500 DRUG

Taurolidine ,citrate 4% and heparin 500 units per ml used as lock solution in tunneled hemodialysis catheter

Group (B) patients used Taurolidine based lock solution as tunneled hemodialysis catheter lock

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All clinically stable adult end stage renal disease patients commence regular hemodialysis through tunneled hemodialysis catheter at Sohar hospital hemodialysis unit.

You may not qualify if:

• Patients with difficult vascular access and the tunneled hemodialysis catheter is the only functioning vascular access .
• Patients with poor flow from the catheter.
• Patients with active infection .
• Patients have displayed allergic reactions to either citrate or taurolidine.
• Patients were taking medication incompatible with either citrate or taurolidine

Sponsors & Collaborators

• Oman Ministry of Health: lead

Study Sites (1)

Sohar hospital

Sohar, Sohar, 00968, Oman

Location

MeSH Terms

Conditions

Catheter-Related Infections

Condition Hierarchy (Ancestors)

Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 4, 2025
• First Posted: July 20, 2025
• Study Start: March 1, 2023
• Primary Completion: February 29, 2024
• Study Completion: July 24, 2024
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

OM (1)