Catheter Related Blood Stream InfectionPhase 2NCT07074821
Antimicrobial Locks for Hemodialysis Catheter Infections
A Phase 2 study testing Taurolidine citrate 4% and heparin 500 in people with Catheter Related Blood Stream Infection and Hemodialysis, run by Oman Ministry of Health at 1 site in Oman.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Catheter Related Blood Stream Infection, Hemodialysis, Vascular Access
- What is being tested?
- Taurolidine citrate 4% and heparin 500
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteOman
- Study dates
- 1 Mar 2023to 24 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All clinically stable adult end stage renal disease patients commence regular hemodialysis through tunneled hemodialysis catheter at Sohar hospital hemodialysis unit.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Tunneled Hemodialysis Catheter Antimicrobial Lock Solution in Prevention of Catheter Related Blood Stream Infection.
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 .
- Being tested
- Taurolidine citrate 4% and heparin 500
- Keywords
- catheter related infection, hemodialysis, Taurolidine
- Medical subject headings
- Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taurolidine citrate 4% and heparin 500Drug
Taurolidine ,citrate 4% and heparin 500 units per ml used as lock solution in tunneled hemodialysis catheter
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Taurolidine citrate 4% and heparin 500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Mar 2023
- Primary completion29 Feb 2024
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter Related Blood Stream InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oman Ministry of Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmed Said Mohammed, Oman Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074821
- Sponsor's protocol ID
- MoH/CSR/24/27480
- Status last verified
- Jul 2025
- First submitted
- 4 May 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Methodology and results
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tunneled Hemodialysis Catheter Antimicrobial Lock Solution in Prevention of Catheter Related Blood Stream Infection.
- ClinicalTrials.gov ID
- NCT07074821
- Acronym / sponsor ID
- MoH/CSR/24/27480
- Keywords
- catheter related infection, hemodialysis, Taurolidine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Oman Ministry of HealthOther government
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Taurolidine citrate 4% and heparin 500Measure incidence of catheter related blood stream infection while patients use Taurolidine based lock solution as catheter lock |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All clinically stable adult end stage renal disease patients commence regular hemodialysis through tunneled hemodialysis catheter at Sohar hospital hemodialysis unit.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taurolidine citrate 4% and heparin 500Taurolidine ,citrate 4% and heparin 500 units per ml used as lock solution in tunneled hemodialysis catheter | Drug | Group (B) patients used Taurolidine based lock solution as tunneled hemodialysis catheter lock |
Primary outcome
Comparison between both groups in terms of incidence of Catheter related blood stream infection
Time frame: one year
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 .
1 secondary outcome
Comparison between both groups in terms of treatment cost
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: Yes. Methodology and results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Taurolidine citrate 4% and heparin 500 in people with Catheter Related Blood Stream Infection and Hemodialysis, run by Oman Ministry of Health at 1 site in Oman.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Oman. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between both groups in terms of incidence of Catheter related blood stream infection (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.