Antimicrobial Locks for Hemodialysis Catheter Infections

NCT ID: NCT07074821

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-07-24

Brief Summary

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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 .

Detailed Description

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Conditions

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Catheter Related Blood Stream Infection Hemodialysis Vascular Access

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Taurolidine citrate 4% and heparin 500

Intervention Type DRUG

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

Interventions

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Taurolidine citrate 4% and heparin 500

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

Intervention Type DRUG

Eligibility Criteria

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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

* 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
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oman Ministry of Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ahmed Said Mohammed

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohar hospital

Sohar, Sohar, Oman

Site Status

Countries

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Oman

Other Identifiers

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MoH/CSR/24/27480

Identifier Type: -

Identifier Source: org_study_id

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