Home Parenteral NutritionPhase 4NCT02009189
Taurolidine Lock in Long Term Parenteral Nutrition
A Phase 4 study testing 2% Taurolidine Lock and 1.35% Taurolidine in people with Home Parenteral Nutrition and Central Venous Catheter, run by Stanley Dudrick's Memorial Hospital at 1 site in Poland.
Trial summary
Taurolidine alone or in combination with citrate have been proposed for locking the catheter to reduce the number of catheter infections. As there is not enough evidence to give recommendations in this regard, the study tested the hipothesis that taurolidine improves the outcome of long term paretneral nutrition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Home Parenteral Nutrition, Central Venous Catheter
- What is being tested?
- 2% Taurolidine Lock and 1.35% Taurolidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2012to Dec 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- home parenteral nutrition for at least months before enrollment
- presence of central venous cathter
Who cannot join
- home nutrition < 12 months
- catheter in peripheral vein
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Value of Taurolidine Lock in Long Term Parenteral Nutrition
Taurolidine alone or in combination with citrate have been proposed for locking the catheter to reduce the number of catheter infections. As there is not enough evidence to give recommendations in this regard, the study tested the hipothesis that taurolidine improves the outcome of long term paretneral nutrition.
- Conditions
- Home Parenteral Nutrition, Central Venous Catheter
- Being tested
- 2% Taurolidine Lock, 1.35% Taurolidine
- Keywords
- home parenteral nutrition, central venous catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% Taurolidine LockDrug
Catheter lock with 2% Taurolidine
1.35% TaurolidineDrug
Catheter lock with 1.35% Taurolidine + citrate
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Saline flush Receives: Drug: 2% Taurolidine Lock; Drug: 1.35% Taurolidine |
| 2% Taurolidine lock | Active comparator | Catheter lock with 2% Taurolidine Receives: Drug: 2% Taurolidine Lock; Drug: 1.35% Taurolidine |
| 1.35% Taurolidine with citrate | Active comparator | Catheter lock with 1.35% Taurolidine + citrate Receives: Drug: 2% Taurolidine Lock; Drug: 1.35% Taurolidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of CVC infections
Number of central venous catheter infections
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startNov 2012
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Home Parenteral NutritionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanley Dudrick's Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanislaw Klek, Stanley Dudrick's Memorial Hospital
- Investigators
- Stanislaw Klek, Assoc Prof, Principal investigator, Stanley Dudrick's Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009189
- Sponsor's protocol ID
- Tauro-1
- Status last verified
- Dec 2013
- First submitted
- 8 Dec 2013
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Pittiruti M, Hamilton H, Biffi R, MacFie J, Pertkiewicz M; ESPEN. ESPEN Guidelines on Parenteral Nutrition: central venous catheters (access, care, diagnosis and therapy of complications). Clin Nutr. 2009 Aug;28(4):365-77. doi: 10.1016/j.clnu.2009.03.015. Epub 2009 May 21.
PubMed 19464090
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Taurolidine Lock in Long Term Parenteral Nutrition
- ClinicalTrials.gov ID
- NCT02009189
- Acronym / sponsor ID
- Tauro-1
- Conditions
- Home Parenteral Nutrition, Central Venous Catheter
- Keywords
- home parenteral nutrition, central venous catheter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stanley Dudrick's Memorial HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Dec 2013 (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.
Taurolidine alone or in combination with citrate have been proposed for locking the catheter to reduce the number of catheter infections. As there is not enough evidence to give recommendations in this regard, the study tested the hipothesis that taurolidine improves the outcome of long term paretneral nutrition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: 2% Taurolidine Lock, Drug: 1.35% TaurolidineSaline flush |
| 2% Taurolidine lock | Active comparator | Drug: 2% Taurolidine Lock, Drug: 1.35% TaurolidineCatheter lock with 2% Taurolidine |
| 1.35% Taurolidine with citrate | Active comparator | Drug: 2% Taurolidine Lock, Drug: 1.35% TaurolidineCatheter lock with 1.35% Taurolidine + citrate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- home parenteral nutrition for at least months before enrollment
- presence of central venous cathter
Key exclusion criteria (2 listed)
- home nutrition < 12 months
- catheter in peripheral vein
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 |
|---|---|---|
| 2% Taurolidine LockCatheter lock with 2% Taurolidine | Drug | 1.35% Taurolidine with citrate, 2% Taurolidine lock, Control |
| 1.35% TaurolidineCatheter lock with 1.35% Taurolidine + citrate | Drug | 1.35% Taurolidine with citrate, 2% Taurolidine lock, Control |
Primary outcome
Number of CVC infections
Time frame: 12 months
Number of central venous catheter infections
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 11 Dec 2013.
- Background: PubMed 19464090Pittiruti M, Hamilton H, Biffi R, MacFie J, Pertkiewicz M; ESPEN. ESPEN Guidelines on Parenteral Nutrition: central venous catheters (access, care, diagnosis and therapy of complications). Clin Nutr. 2009 Aug;28(4):365-77. doi: 10.1016/j.clnu.2009.03.015. Epub 2009 May 21.
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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.
Stanislaw Klek, Assoc Prof principal investigator
Stanley Dudrick's Memorial Hospital
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 2% Taurolidine Lock and 1.35% Taurolidine in people with Home Parenteral Nutrition and Central Venous Catheter, run by Stanley Dudrick's Memorial Hospital at 1 site in Poland.
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 2 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 11 Dec 2013. 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 Poland. 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. Some participants in this study may receive a placebo. 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?
Number of CVC infections (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02009189, which also lists 1 linked publication.
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 11 Dec 2013.