Clinical Trial Comparing Catheter Lock Solutions TaurolockTMHep 100 and Heparin 100 IE/ml.

NCT01948245 | Unknown Phase 4

• 2 other identifiers: H-4-2013-12738202
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Mean number of catheter related blood stream infections(CRBSI)/ 1000 catheter days in each group

  24 months

Secondary Outcomes (6)

• Median time to a catheter related blood stream infection(CRBSI) in each group.

  24 months

• Number and frequency of catheter removals due to catheter-related infections in each group

  24 months

• Number and frequency of exit site infections in each group

  24 months

• Median time to catheter removal due to catheter-related infections in each group

  24 months

• Number and frequency of catheter occlusions in each group

  24 months

Other Outcomes (2)

• Patient satisfaction with the assigned catheter lock solution in each group

  24 months

• Costs of catheter lock solution plus cost of hospitalization, unscheduled outpatient-clinic consultations, drug treatment costs of infections and catheter changes

  24 months

Study Arms (2)

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).

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).

Device: Heparin 100 IE/ml

Interventions

TaurolockTMHep100 DEVICE

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.

Also known as: Taurolidine 1,35%/citrate 4 %/heparin 100 IE/ml

TaurolockTMHep100

Heparin 100 IE/ml DEVICE

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/ml

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Palle Bekker Jeppesen: lead
• TauroPharm: collaborator

Study Sites (1)

Rigshospitalet, abdominalcentret, Medicinsk Gastroenterologisk klinik CA, 2121

Copenhagen, 2100, Denmark

Location

Related Publications (2)

• 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.

  PMID: 29722835 DERIVED

• 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.

  PMID: 28793993 DERIVED

MeSH Terms

Conditions

Pyloric Stenosis, Hypertrophic

Condition Hierarchy (Ancestors)

Pyloric Stenosis; Gastric Outlet Obstruction; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Palle B Jeppesen, Ass. Prof.

  Medicinsk Gastroenterologisk klinik CA, 2121, Abdominal centret, Rigshospitalet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistent professor

Study Record Dates

• First Submitted: September 16, 2013
• First Posted: September 23, 2013
• Study Start: October 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 6, 2016

Record last verified: 2016-04

Locations

DK (1)