Back to resultsClinical Trial Comparing Catheter Lock Solutions TaurolockTMHep 100 and Heparin 100 IE/ml.
Primary Purpose
Catheter-related Bloodstream Infection (CRBSI) Nos
Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
TaurolockTMHep100
Heparin 100 IE/ml
Sponsored by
About this trial
This is an interventional prevention trial for Catheter-related Bloodstream Infection (CRBSI) Nos focused on measuring Catheter Related Blood Stream Infection, Long-term intestinal Failure, Taurolidine, Catheter lock solution, Antimicrobial agent, Home Parenteral Nutrition, Anti-infective agents
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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
- 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
Sites / Locations
- Rigshospitalet, abdominalcentret, Medicinsk Gastroenterologisk klinik CA, 2121
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
TaurolockTMHep100
Heparin 100 IE/ml
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
Mean number of catheter related blood stream infections(CRBSI)/ 1000 catheter days in each group
Secondary Outcome Measures
Median time to a catheter related blood stream infection(CRBSI) in each group.
Number and frequency of catheter removals due to catheter-related infections in each group
Number and frequency of exit site infections in each group
Median time to catheter removal due to catheter-related infections in each group
Number and frequency of catheter occlusions in each group
Number and frequency of patients having serious adverse event and adverse event in each group
Full Information
NCT ID
NCT01948245
First Posted
September 16, 2013
Last Updated
April 5, 2016
Sponsor
Palle Bekker Jeppesen
Collaborators
TauroPharm
1. Study Identification
Unique Protocol Identification Number
NCT01948245
Brief Title
Clinical Trial Comparing Catheter Lock Solutions TaurolockTMHep 100 and Heparin 100 IE/ml.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Palle Bekker Jeppesen
Collaborators
TauroPharm
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter-related Bloodstream Infection (CRBSI) Nos
Keywords
Catheter Related Blood Stream Infection, Long-term intestinal Failure, Taurolidine, Catheter lock solution, Antimicrobial agent, Home Parenteral Nutrition, Anti-infective agents
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TaurolockTMHep100
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Heparin 100 IE/ml
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
TaurolockTMHep100
Other Intervention Name(s)
Taurolidine 1,35%/citrate 4 %/heparin 100 IE/ml
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Heparin 100 IE/ml
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean number of catheter related blood stream infections(CRBSI)/ 1000 catheter days in each group
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Median time to a catheter related blood stream infection(CRBSI) in each group.
Time Frame
24 months
Title
Number and frequency of catheter removals due to catheter-related infections in each group
Time Frame
24 months
Title
Number and frequency of exit site infections in each group
Time Frame
24 months
Title
Median time to catheter removal due to catheter-related infections in each group
Time Frame
24 months
Title
Number and frequency of catheter occlusions in each group
Time Frame
24 months
Title
Number and frequency of patients having serious adverse event and adverse event in each group
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Patient satisfaction with the assigned catheter lock solution in each group
Description
1= not at all satisfied, 2= unsatisfied, 3= satisfied, 4= very satisfied
Time Frame
24 months
Title
Costs of catheter lock solution plus cost of hospitalization, unscheduled outpatient-clinic consultations, drug treatment costs of infections and catheter changes
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Palle B Jeppesen, Ass. Prof.
Organizational Affiliation
Medicinsk Gastroenterologisk klinik CA, 2121, Abdominal centret, Rigshospitalet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet, abdominalcentret, Medicinsk Gastroenterologisk klinik CA, 2121
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
29722835
Citation
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.
Results Reference
derived
PubMed Identifier
28793993
Citation
Tribler 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.
Results Reference
derived
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Clinical Trial Comparing Catheter Lock Solutions TaurolockTMHep 100 and Heparin 100 IE/ml.
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