End Stage Renal DiseasePhase 3NCT00749619
Addition of Heparin to Taurolock-TM CLS in HD Patients With TCC Dose it Improve Catheter Patency Problems ?
A Phase 3 study testing Catheter Lock Solution Taurolidine and Citrate, Catheter Lock Solution :Taurolidine and Citrate and Heparin and Catheter Lock Solution : Heparin in people with End Stage Renal Disease and Hemodialysis, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
Addition of Heparin to the Catheter Lock Solution (CLS): Taurolock-TM will improve the vascular patency compared to Taurolock-TM alone , in hemodialysis patients with Tunneled Cuffed Catheter(TCC) as vascular access. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End Stage Renal Disease, Hemodialysis
- What is being tested?
- Catheter Lock Solution Taurolidine and Citrate, Catheter Lock Solution :Taurolidine and Citrate and Heparin and Catheter Lock Solution : Heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- May 2007to Aug 2008
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hemodialysis patients with new TCC
- Informed Consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Addition of Heparin to the Catheter Lock Solution (CLS): Taurolock-TM will improve the vascular patency compared to Taurolock-TM alone , in hemodialysis patients with Tunneled Cuffed Catheter(TCC) as vascular access.
Read the detailed description
Bacteremia and thrombosis are the major complications of TCC used for hemodialysis.Instilation of CLS containing antibiotic-anticoagulant solution in the end of each dialysis session till the next dialysis ,can prevent Catheter related bacteremia (CRB).In previous study in our department, Taurolock-TM decreased the rate of CRB but increased the incidence of catheter malfunction.
The aim of the study is to investigate the influence of of Heparin addition to CLS-Taurolock- TM ( Taurolidine \&citrate 4%) in prevention of catheter patency problems in HD patients with TCC, in addition to CRB prevention.
Methods : Patients with newly inserted TCC for HD enrolled and randomized to receive one of three CLS types : group 1- Taurolock-TM, Group 2 - Taurolock-TM and Heparin , Group 3- Heparin .Patients were followed for 6 monthes.
The objective of the study is to investigate the effect of Taurolock TM with heparin on the rate of CRB and vascular patency.
- Conditions
- End Stage Renal Disease, Hemodialysis
- Being tested
- Catheter Lock Solution Taurolidine and Citrate, Catheter Lock Solution :Taurolidine and Citrate and Heparin, Catheter Lock Solution : Heparin
- Keywords
- Tunneled Cuffed Catheter, Catheter Lock Solution, Catheter Related Bacteremia
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter Lock Solution Taurolidine and CitrateOther
Catheter Lock Solution :Taurolidine and Citrate and HeparinOther
Catheter Lock Solution : HeparinOther
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Other: Catheter Lock Solution Taurolidine and Citrate |
| B | Experimental | Not described Receives: Other: Catheter Lock Solution :Taurolidine and Citrate and Heparin |
| C | No intervention | Not described Receives: Other: Catheter Lock Solution : Heparin |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startMay 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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 3
- Primary purpose
- Prevention
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749619
- Sponsor's protocol ID
- TAURO 070908
- Status last verified
- Sep 2008
- First submitted
- 7 Sep 2008
- Last updated
- 9 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Heparin to Taurolock-TM CLS in HD Patients With TCC Dose it Improve Catheter Patency Problems ?
- ClinicalTrials.gov ID
- NCT00749619
- Acronym / sponsor ID
- TAURO 070908
- Conditions
- End Stage Renal Disease, Hemodialysis
- Keywords
- Tunneled Cuffed Catheter, Catheter Lock Solution, Catheter Related Bacteremia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- May 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 9 Sep 2008 (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.
Addition of Heparin to the Catheter Lock Solution (CLS): Taurolock-TM will improve the vascular patency compared to Taurolock-TM alone , in hemodialysis patients with Tunneled Cuffed Catheter(TCC) as vascular access.
Detailed description
Bacteremia and thrombosis are the major complications of TCC used for hemodialysis.Instilation of CLS containing antibiotic-anticoagulant solution in the end of each dialysis session till the next dialysis ,can prevent Catheter related bacteremia (CRB).In previous study in our department, Taurolock-TM decreased the rate of CRB but increased the incidence of catheter malfunction.
The aim of the study is to investigate the influence of of Heparin addition to CLS-Taurolock- TM ( Taurolidine \&citrate 4%) in prevention of catheter patency problems in HD patients with TCC, in addition to CRB prevention.
Methods : Patients with newly inserted TCC for HD enrolled and randomized to receive one of three CLS types : group 1- Taurolock-TM, Group 2 - Taurolock-TM and Heparin , Group 3- Heparin .Patients were followed for 6 monthes.
The objective of the study is to investigate the effect of Taurolock TM with heparin on the rate of CRB and vascular patency.
Study design
- Primary purpose
- Prevention
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: Catheter Lock Solution Taurolidine and Citrate |
| B | Experimental | Other: Catheter Lock Solution :Taurolidine and Citrate and Heparin |
| C | No intervention | Other: Catheter Lock Solution : Heparin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Hemodialysis patients with new TCC
- Informed Consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Catheter Lock Solution Taurolidine and Citrate | Other | A |
| Catheter Lock Solution :Taurolidine and Citrate and Heparin | Other | B |
| Catheter Lock Solution : Heparin | Other | C |
Primary outcome
Not reported in the source record.
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 9 Sep 2008.
Related trials for End Stage Renal Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
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 3 study testing Catheter Lock Solution Taurolidine and Citrate, Catheter Lock Solution :Taurolidine and Citrate and Heparin and Catheter Lock Solution : Heparin in people with End Stage Renal Disease and Hemodialysis, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
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 0 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 9 Sep 2008. 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 Israel. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
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 9 Sep 2008.