Catheter-related Bloodstream Infection (CRBSI) NosPhase 4NCT01948245
Clinical Trial Comparing Catheter Lock Solutions TaurolockTMHep 100 and Heparin 100 IE/ml.
A Phase 4 study testing TaurolockTMHep100 and Heparin 100 IE/ml in people with Catheter-related Bloodstream Infection (CRBSI) Nos, run by Palle Bekker Jeppesen at 1 site in Denmark.
Trial summary
The purpose of the investigation is to compare two catheter lock solutions (TaurolockTMHep100 and Heparin 100 IE/ml), on the occurence of catheter related blood stream infection, in patients with intestinal failure and a central venous access device for home parenteral nutrition. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Catheter-related Bloodstream Infection (CRBSI) Nos
- What is being tested?
- TaurolockTMHep100 and Heparin 100 IE/ml
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2013to Dec 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with long-term intestinal failure who will receive PS at least 2 times /week over a subcutaneously tunneled single-lumen CVC (Hickman/Broviac) for at least one year.
- Estimated life expectancy ≥1 year
- Male or female patient aged 18 - 80 years
- Patient is fully able to understand the nature of the proposed intervention and gives written informed consent before entering the trial.
Who cannot join
- Patients who:
- can not be expected to comply with the trial plan (e.g. substance abuse, mental condition)
- has significant cardiovascular disease such as unstable angina, recent acute myocardial infarction or recent cerebral vascular accident (within 6 weeks); a cardiac rhythm which in the investigators judgment may result in significant hemodynamic effects
- has a known hypersensitivity/allergy to TauroLockTMHep 100 or heparin and/or their excipients.
- is pregnant, lactating, or nursing
- has abnormal blood coagulation due to primary disease or due to treatment with anticoagulants (warfarin/phenprocoumon, unfractionated heparin, low- molecular heparin), with the clinical blood tests INR and APTT, outside the intervals given below, at the time of inclusion. Patients with unfractionated Heparin 100 IE/ml used as a catheter lock, do not need to have APTT tested before enrollment. Patients treated with Low-Molecular Heparin, needs control of INR, thrombocytes and plasma-antifactor Xa, and If the patient has increased bleeding risk judge by disease and clinical blood tests, the patient can´t be included in the trial. INR 0.9-3.0 (warfarin/ phenprocoumon) APTT needs to be in the range 25-100 seconds (Unfractionated Heparin treatment) Plasma-antifactor Xa( outside recommended intervals (pro.medicin.dk), which are dependent on administration form and number of daily administrations ). Thrombocytes 100- 600 x109/L
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- Patients with a new catheter-related thrombosis in the last 3 months prior to inclusion.
- has received an investigational drug within 30 days of trial entry
- has received a TauroLockTMHep 100 solution previously
- has an antibiotic coated, silver impregnated or antimicrobial cuff catheter
- has compromised skin integrity, including any infection at the insertion site
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Rigshospitalet, abdominalcentret, Medicinsk Gastroenterologisk klinik CA, 2121
Copenhagen, 2100
About this study
Official title: A Double Blinded, Randomized, Controlled Investigation of Taurolidine-citrate/Heparin Catheter Lock Solution Versus Heparin in Patients on Home Parenteral Nutrition With Previously Proven High Risk of Catheter Related Blood Stream Infections.
The purpose of the investigation is to compare two catheter lock solutions (TaurolockTMHep100 and Heparin 100 IE/ml), on the occurence of catheter related blood stream infection, in patients with intestinal failure and a central venous access device for home parenteral nutrition.
Read the detailed description
Patients with long-term intestinal failure are dependent on Home Parenteral Nutrition(HPN) delivered through a central venous access device(CVAD), placed as a subcutaneous tunneled catheter(Broviac). Catheter Related Blood Stream Infections(CRBSI) is a frequent complication leading to increased morbidity, hospital admissions, cost, and risk of repeated replacement of their tunneled catheter. The infections often originate from contamination of the catheter hub, and growth of microorganisms on the inner lumen of the catheter imbedded in a biofilm. To prevent infections good hygiene guidelines and the use of a catheter lock solution is applied.
The primary objective is to compare two catheter lock solutions, TaurolockTMHep100 and Heparin 100 IE/ml, on the occurence of CRBSI. The secondary objectives are to compare the two devices according to other efficacy parameters, time to infection, cost and resource utility, tolerability and safety.
Patients with a prior high risk of CRBSI will be included. Patients will instill the solution in their CVAD after each infusion of HPN, varying between minimum twice per week to once daily, depending on their individual HPN programme.
Before the blinded randomization the patients will be paired according to gender, age and prior infection risk.
Duration of the instillation will be 24 month or until outcome(CRBSI) accure.
- Being tested
- TaurolockTMHep100, Heparin 100 IE/ml
- Keywords
- Catheter Related Blood Stream Infection, Long-term intestinal Failure, Taurolidine, Catheter lock solution, Antimicrobial agent, Home Parenteral Nutrition, Anti-infective agents
- Medical subject headings
- Pyloric Stenosis, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaurolockTMHep100Device
Also called Taurolidine 1,35%/citrate 4 %/heparin 100 IE/ml
2-4 ml of the catheter lock solution will be instilled after each infusion of parenteral nutrition/intravenous fluids varying between twice weekly to once daily, depending on the individual patients HPN programme. The instilled solution is kept in the catheter until the next infusion, with a prior flushing with 10 ml of Saline both before the instillation of the catheter lock and before infusion of HPN/fluids.
Heparin 100 IE/mlDevice
2-4 ml of the catheter lock solution will be instilled after each infusion of parenteral nutrition/intravenous fluids varying between twice weekly to once daily, depending on the individual patients HPN programme. The instilled solution is kept in the catheter until the next infusion, with a prior flushing with 10 ml of Saline both before the instillation of the catheter lock and before infusion of HPN/fluids.
| Study group | Role | What they receive |
|---|---|---|
| TaurolockTMHep100 | Active comparator | 2-4 ml of TaurolockTMHep100 will be instilled into the central venous access device (CVAD)after each infusion of parenteral nutrition/intravenous fluids. The instillation varying between twice per week to once daily depending on the patients individual HPN programme. The catheter lock solution is kept in situ in the lumen to the next infusion.
The duration of TaurolockTMHep100 administration will be maximum 24 month or until occurence of primary outcome(CRBSI). Receives: Device: TaurolockTMHep100 |
| Heparin 100 IE/ml | Placebo comparator | 2-4 ml of Heparin 100 IE/mk will be instilled into the central venous access device (CVAD)after each infusion of parenteral nutrition/intravenous fluids. The instillation varying between twice per week to once daily depending on the patients individual HPN programme. The catheter lock solution is kept in situ in the lumen to the next infusion.
The duration of Heparin 100 IE/ml administration will be maximum 24 month or until occurence of primary outcome(CRBSI). Receives: Device: Heparin 100 IE/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of catheter related blood stream infections(CRBSI)/ 1000 catheter days in each group
Measured: 24 months
Secondary outcomes (6)
Median time to a catheter related blood stream infection(CRBSI) in each group.
Measured: 24 months
Number and frequency of catheter removals due to catheter-related infections in each group
Measured: 24 months
Number and frequency of exit site infections in each group
Measured: 24 months
Median time to catheter removal due to catheter-related infections in each group
Measured: 24 months
Number and frequency of catheter occlusions in each group
Measured: 24 months
Number and frequency of patients having serious adverse event and adverse event in each group
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Catheter-related Bloodstream Infection (CRBSI) NosStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palle Bekker Jeppesen
- Sponsor type
- University, hospital or other
- Collaborators
- TauroPharm
- Responsible party
- Sponsor-investigator, Palle Bekker Jeppesen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Palle B Jeppesen, Ass. Prof., Principal investigator, Medicinsk Gastroenterologisk klinik CA, 2121, Abdominal centret, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948245
- Sponsor's protocol ID
- H-4-2013-127
- Other IDs
- 38202
- Status last verified
- Apr 2016
- First submitted
- 16 Sep 2013
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Tribler S, Brandt CF, Fuglsang KA, Staun M, Broebech P, Moser CE, Scheike T, Jeppesen PB. Catheter-related bloodstream infections in patients with intestinal failure receiving home parenteral support: risks related to a catheter-salvage strategy. Am J Clin Nutr. 2018 May 1;107(5):743-753. doi: 10.1093/ajcn/nqy010.
PubMed 29722835Tribler S, Brandt CF, Petersen AH, Petersen JH, Fuglsang KA, Staun M, Broebech P, Moser CE, Jeppesen PB. Taurolidine-citrate-heparin lock reduces catheter-related bloodstream infections in intestinal failure patients dependent on home parenteral support: a randomized, placebo-controlled trial. Am J Clin Nutr. 2017 Sep;106(3):839-848. doi: 10.3945/ajcn.117.158964. Epub 2017 Aug 9.
PubMed 28793993
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blinded, Randomized, Controlled Investigation of Taurolidine-citrate/Heparin Catheter Lock Solution Versus Heparin in Patients on Home Parenteral Nutrition With Previously Proven High Risk of Catheter Related Blood Stream Infections.
- ClinicalTrials.gov ID
- NCT01948245
- Acronym / sponsor ID
- H-4-2013-127
- Keywords
- Catheter Related Blood Stream Infection, Long-term intestinal Failure, Taurolidine, Catheter lock solution, Antimicrobial agent, Home Parenteral Nutrition, Anti-infective agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Palle Bekker JeppesenUniversity, hospital or other
- Collaborators
- TauroPharm
- Study start
- Oct 2013
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 23 Sep 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.
The purpose of the investigation is to compare two catheter lock solutions (TaurolockTMHep100 and Heparin 100 IE/ml), on the occurence of catheter related blood stream infection, in patients with intestinal failure and a central venous access device for home parenteral nutrition.
Detailed description
Patients with long-term intestinal failure are dependent on Home Parenteral Nutrition(HPN) delivered through a central venous access device(CVAD), placed as a subcutaneous tunneled catheter(Broviac). Catheter Related Blood Stream Infections(CRBSI) is a frequent complication leading to increased morbidity, hospital admissions, cost, and risk of repeated replacement of their tunneled catheter. The infections often originate from contamination of the catheter hub, and growth of microorganisms on the inner lumen of the catheter imbedded in a biofilm. To prevent infections good hygiene guidelines and the use of a catheter lock solution is applied.
The primary objective is to compare two catheter lock solutions, TaurolockTMHep100 and Heparin 100 IE/ml, on the occurence of CRBSI. The secondary objectives are to compare the two devices according to other efficacy parameters, time to infection, cost and resource utility, tolerability and safety.
Patients with a prior high risk of CRBSI will be included. Patients will instill the solution in their CVAD after each infusion of HPN, varying between minimum twice per week to once daily, depending on their individual HPN programme.
Before the blinded randomization the patients will be paired according to gender, age and prior infection risk.
Duration of the instillation will be 24 month or until outcome(CRBSI) accure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TaurolockTMHep100 | Active comparator | Device: TaurolockTMHep1002-4 ml of TaurolockTMHep100 will be instilled into the central venous access device (CVAD)after each infusion of parenteral nutrition/intravenous fluids. The instillation varying between twice per week to once daily depending on the patients individual HPN programme. The catheter lock solution is kept in situ in the lumen to the next infusion. The duration of TaurolockTMHep100 administration will be maximum 24 month or until occurence of primary outcome(CRBSI). |
| Heparin 100 IE/ml | Placebo comparator | Device: Heparin 100 IE/ml2-4 ml of Heparin 100 IE/mk will be instilled into the central venous access device (CVAD)after each infusion of parenteral nutrition/intravenous fluids. The instillation varying between twice per week to once daily depending on the patients individual HPN programme. The catheter lock solution is kept in situ in the lumen to the next infusion. The duration of Heparin 100 IE/ml administration will be maximum 24 month or until occurence of primary outcome(CRBSI). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with long-term intestinal failure who will receive PS at least 2 times /week over a subcutaneously tunneled single-lumen CVC (Hickman/Broviac) for at least one year.
- Estimated life expectancy ≥1 year
- Male or female patient aged 18 - 80 years
- Patient is fully able to understand the nature of the proposed intervention and gives written informed consent before entering the trial.
Key exclusion criteria (11 listed)
- can not be expected to comply with the trial plan (e.g. substance abuse, mental condition)
- has significant cardiovascular disease such as unstable angina, recent acute myocardial infarction or recent cerebral vascular accident (within 6 weeks); a cardiac rhythm which in the investigators judgment may result in significant hemodynamic effects
- has a known hypersensitivity/allergy to TauroLockTMHep 100 or heparin and/or their excipients.
- is pregnant, lactating, or nursing
- has abnormal blood coagulation due to primary disease or due to treatment with anticoagulants (warfarin/phenprocoumon, unfractionated heparin, low- molecular heparin), with the clinical blood tests INR and APTT, outside the intervals given below, at the time of inclusion. Patients with unfractionated Heparin 100 IE/ml used as a catheter lock, do not need to have APTT tested before enrollment. Patients treated with Low-Molecular Heparin, needs control of INR, thrombocytes and plasma-antifactor Xa, and If the patient has increased bleeding risk judge by disease and clinical blood tests, the patient can´t be included in the trial. INR 0.9-3.0 (warfarin/ phenprocoumon) APTT needs to be in the range 25-100 seconds (Unfractionated Heparin treatment) Plasma-antifactor Xa( outside recommended intervals (pro.medicin.dk), which are dependent on administration form and number of daily administrations ). Thrombocytes 100- 600 x109/L
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 |
|---|---|---|
| TaurolockTMHep100Also: Taurolidine 1,35%/citrate 4 %/heparin 100 IE/ml2-4 ml of the catheter lock solution will be instilled after each infusion of parenteral nutrition/intravenous fluids varying between twice weekly to once daily, depending on the individual patients HPN programme. The instilled solution is kept in the catheter until the next infusion, with a prior flushing with 10 ml of Saline both before the instillation of the catheter lock and before infusion of HPN/fluids. | Device | TaurolockTMHep100 |
| Heparin 100 IE/ml2-4 ml of the catheter lock solution will be instilled after each infusion of parenteral nutrition/intravenous fluids varying between twice weekly to once daily, depending on the individual patients HPN programme. The instilled solution is kept in the catheter until the next infusion, with a prior flushing with 10 ml of Saline both before the instillation of the catheter lock and before infusion of HPN/fluids. | Device | Heparin 100 IE/ml |
Primary outcome
Mean number of catheter related blood stream infections(CRBSI)/ 1000 catheter days in each group
Time frame: 24 months
6 secondary outcomes
Median time to a catheter related blood stream infection(CRBSI) in each group.
Time frame: 24 months
Number and frequency of catheter removals due to catheter-related infections in each group
Time frame: 24 months
Number and frequency of exit site infections in each group
Time frame: 24 months
Median time to catheter removal due to catheter-related infections in each group
Time frame: 24 months
Number and frequency of catheter occlusions in each group
Time frame: 24 months
Number and frequency of patients having serious adverse event and adverse event in each group
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Derived from this study: PubMed 29722835Tribler S, Brandt CF, Fuglsang KA, Staun M, Broebech P, Moser CE, Scheike T, Jeppesen PB. Catheter-related bloodstream infections in patients with intestinal failure receiving home parenteral support: risks related to a catheter-salvage strategy. Am J Clin Nutr. 2018 May 1;107(5):743-753. doi: 10.1093/ajcn/nqy010.
- Derived from this study: PubMed 28793993Tribler S, Brandt CF, Petersen AH, Petersen JH, Fuglsang KA, Staun M, Broebech P, Moser CE, Jeppesen PB. Taurolidine-citrate-heparin lock reduces catheter-related bloodstream infections in intestinal failure patients dependent on home parenteral support: a randomized, placebo-controlled trial. Am J Clin Nutr. 2017 Sep;106(3):839-848. doi: 10.3945/ajcn.117.158964. Epub 2017 Aug 9.
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.
Palle B Jeppesen, Ass. Prof. principal investigator
Medicinsk Gastroenterologisk klinik CA, 2121, Abdominal centret, Rigshospitalet
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 TaurolockTMHep100 and Heparin 100 IE/ml in people with Catheter-related Bloodstream Infection (CRBSI) Nos, run by Palle Bekker Jeppesen at 1 site in Denmark.
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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 6 Apr 2016. 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 Denmark. 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?
Results are not available in the source record.
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?
Mean number of catheter related blood stream infections(CRBSI)/ 1000 catheter days in each group (time frame: 24 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 NCT01948245, which also lists 2 linked publications.
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 6 Apr 2016.