Renal DialysisPhase 4NCT01243710
Taurolidine in Haemodialysis Catheter Related Bacteraemia
A Phase 4 study testing Taurolidine with heparin (500 units/ ml) in people with Renal Dialysis and Catheter-Related Infections, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine whether taurolidine with heparin locking solution prevents recurrence of central venous catheter related blood stream infections in haemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Renal Dialysis, Catheter-Related Infections
- What is being tested?
- Taurolidine with heparin (500 units/ ml)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2010to Dec 2012
- Phase
- Phase 4
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Haemodialysis patients established on dialysis for greater than 90 days who dialyse in-centre at any of the satellite dialysis units of Imperial College Healthcare NHS Trust
- All patients with a recent catheter related bacteraemia with an identified organism grown on microbiological culture and treated without catheter removal will be eligible for inclusion.
Who cannot join
- Those individuals in whom attempted catheter salvage is clinically not indicated.
- Unable to provide informed consent
- Known allergy to sodium citrate, heparin or taurolidine.
- Bleeding diathesis or physical cause for active bleeding.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Healthcare NHS Trust
London, W12 0HS
About this study
Official title: A Randomised Controlled Trial of Taurolidine With Heparin for Prevention of Recurrence of Catheter Related Bacteraemia in Haemodialysis Patients.
The purpose of this study is to determine whether taurolidine with heparin locking solution prevents recurrence of central venous catheter related blood stream infections in haemodialysis patients.
Read the detailed description
Infections related to long-term haemodialysis catheters are associated with significant morbidity. A high proportion of those people initially treated with antibiotics to clear a catheter infection develop a second infection within six months, necessitating the removal and replacement of the dialysis catheter.
This study will examine the efficacy of an antimicrobial catheter locking solution called taurolidine with heparin in preventing a second infection within six months of a significant infection. This solution will be compared with the solution used currently (heparin) which is left inside the catheter between dialysis sessions.
This is a clinical study given that antimicrobial catheter locks are thought to reduce the risk of blood stream infections and the ultimate need for catheter change. However, there is concern that the absence of an anticoagulant in the lock solution increases the risk of catheter thrombosis, again requiring a change of catheter but for a separate reason. It is unclear therefore whether a solution containing both taurolidine (an antimicrobial) and heparin (an anticoagulant) will increase catheter survival.
The results of this study will help guide the appropriate suse of locking solutions in the future.
- Conditions
- Renal Dialysis, Catheter-Related Infections
- Being tested
- Taurolidine with heparin (500 units/ ml)
- 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 with heparin (500 units/ ml)Device
Also called Taurolock Hep500
Central venous catheter will be locked (the designated volume required to fill the dead space) with taurolidine with heparin after each dialysis session. The control arm will be locked with heparin as is current practice.
| Study group | Role | What they receive |
|---|---|---|
| Taurolidine with heparin | Experimental | Not described Receives: Device: Taurolidine with heparin (500 units/ ml) |
| Heparin | Active comparator | Not described Receives: Device: Taurolidine with heparin (500 units/ ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of bacteraemia-free catheter survival
Measured: Catheter survival measured up to six months from enrollment date.
Secondary outcomes (4)
Catheter related flow problems
Quantified by use of:
- Urokinase locks
- Systemic urokinase infusions
Measured: Catheter survival measured up to six months from enrollment date.
Hospital admissions for catheter related problems including catheter removal
Measured: Catheter survival measured up to six months from enrollment date.
Erythropoietin resistance
Quantified by:
- Erythropoietin dose
- Number of blood transfusions required
Measured: Catheter survival measured up to six months from enrollment date.
Haemodialysis adequacy
Quantified by:
- Kt/V
- Blood flows
Measured: Catheter survival measured up to six months from enrollment date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DialysisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neill Duncan, MBBS, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243710
- Sponsor's protocol ID
- DUNN1007
- Status last verified
- Jul 2020
- First submitted
- 17 Nov 2010
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Taurolidine With Heparin for Prevention of Recurrence of Catheter Related Bacteraemia in Haemodialysis Patients.
- ClinicalTrials.gov ID
- NCT01243710
- Acronym / sponsor ID
- DUNN1007
- Conditions
- Renal Dialysis, Catheter-Related Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 18 Nov 2010 (estimated)
- 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.
The purpose of this study is to determine whether taurolidine with heparin locking solution prevents recurrence of central venous catheter related blood stream infections in haemodialysis patients.
Detailed description
Infections related to long-term haemodialysis catheters are associated with significant morbidity. A high proportion of those people initially treated with antibiotics to clear a catheter infection develop a second infection within six months, necessitating the removal and replacement of the dialysis catheter.
This study will examine the efficacy of an antimicrobial catheter locking solution called taurolidine with heparin in preventing a second infection within six months of a significant infection. This solution will be compared with the solution used currently (heparin) which is left inside the catheter between dialysis sessions.
This is a clinical study given that antimicrobial catheter locks are thought to reduce the risk of blood stream infections and the ultimate need for catheter change. However, there is concern that the absence of an anticoagulant in the lock solution increases the risk of catheter thrombosis, again requiring a change of catheter but for a separate reason. It is unclear therefore whether a solution containing both taurolidine (an antimicrobial) and heparin (an anticoagulant) will increase catheter survival.
The results of this study will help guide the appropriate suse of locking solutions in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taurolidine with heparin | Experimental | Device: Taurolidine with heparin (500 units/ ml) |
| Heparin | Active comparator | Device: Taurolidine with heparin (500 units/ ml) |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Haemodialysis patients established on dialysis for greater than 90 days who dialyse in-centre at any of the satellite dialysis units of Imperial College Healthcare NHS Trust
- All patients with a recent catheter related bacteraemia with an identified organism grown on microbiological culture and treated without catheter removal will be eligible for inclusion.
Key exclusion criteria (4 listed)
- Those individuals in whom attempted catheter salvage is clinically not indicated.
- Unable to provide informed consent
- Known allergy to sodium citrate, heparin or taurolidine.
- Bleeding diathesis or physical cause for active bleeding.
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 with heparin (500 units/ ml)Also: Taurolock Hep500Central venous catheter will be locked (the designated volume required to fill the dead space) with taurolidine with heparin after each dialysis session. The control arm will be locked with heparin as is current practice. | Device | Heparin, Taurolidine with heparin |
Primary outcome
Duration of bacteraemia-free catheter survival
Time frame: Catheter survival measured up to six months from enrollment date.
4 secondary outcomes
Catheter related flow problems
Time frame: Catheter survival measured up to six months from enrollment date.
Hospital admissions for catheter related problems including catheter removal
Time frame: Catheter survival measured up to six months from enrollment date.
Erythropoietin resistance
Time frame: Catheter survival measured up to six months from enrollment date.
Haemodialysis adequacy
Time frame: Catheter survival measured up to six months from enrollment date.
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 30 Jul 2020.
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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.
Neill Duncan, MBBS principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Taurolidine with heparin (500 units/ ml) in people with Renal Dialysis and Catheter-Related Infections, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
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 2 inclusion and 4 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 30 Jul 2020. 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 United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Duration of bacteraemia-free catheter survival (time frame: Catheter survival measured up to six months from enrollment date.). 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 30 Jul 2020.