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CompletedNCT07074821Updated Jul 20, 2025

Antimicrobial Locks for Hemodialysis Catheter Infections

A Phase 2 interventional study of Taurolidine citrate 4% and heparin 500 in Catheter Related Blood Stream Infection, Hemodialysis and Vascular Access, sponsored by Oman Ministry of Health. Completed at 1 site in Oman. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2025-07-20.

Sponsored by Oman Ministry of Health · Phase 2, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Mar 2023, registered May 2025).
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
13 Years and older
Sex
All
01

Study 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 .

02

Conditions studied

  • Catheter Related Blood Stream Infection
  • Hemodialysis
  • Vascular Access

Keywords

  • catheter related infection
  • hemodialysis
  • Taurolidine
03

In context

Catheter-Related Infections

107 studies on the registry are indexed under Catheter-Related Infections; 16 are open to participants now.

This study's enrollment of 100 is below the median of 150 across 76 interventional studies indexed under Catheter-Related Infections.

Browse Catheter-Related Infections studies →

Lead sponsor

Oman Ministry of Health is the lead sponsor of 18 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • No intervention
    Group (A) patients used usual Heparin used as tunneled hemodialysis lock solution

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

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

    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

  • DrugTaurolidine citrate 4% and heparin 500

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

06

What researchers measure

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 .

    Time frame: one year

Secondary outcomes

  1. Comparison between both groups in terms of treatment cost

    The secondary outcome measure was to compare the treatment cost in both groups to determine cost effectiveness

    Time frame: one year

07

Study locations

1 site
  • Sohar hospital
    Sohar, Sohar 00968, Oman
08

References and documents

Individual participant data

Plan to share: Yes — Methodology and results

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07074821
Lead sponsor
Oman Ministry of Health
Responsible party
Ahmed Said Mohammed (Principal investigator, Oman Ministry of Health) — Principal investigator
First posted
Jul 20, 2025
Start date
Mar 1, 2023
Primary completion
Feb 29, 2024
Completion
Jul 24, 2024
Last update
Jul 20, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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