NCT01826526

Brief Summary

The purpose of this study is to determine if TauroSept® taurolidine 2% is more efficient than saline solution 0.9% as a catheter lock solution in preventing catheter related blood stream infections in patients with home parenteral nutrition.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
6 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 8, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

3.3 years

First QC Date

March 5, 2013

Last Update Submit

December 3, 2016

Conditions

Catheter Related Blood Stream Infections

Outcome Measures

Primary Outcomes (1)

  • Mean number of catheter related blood stream infections CRBSI/1'000 catheter days in each group

    12 months

Secondary Outcomes (1)

  • Median time to a catheter related blood stream infection CRBSI per patient per group

    12 months

Study Arms (2)

TauroSept®

ACTIVE COMPARATOR

5 ml of TauroSept® will be instilled into the catheter (CVAD) each time after total parenteral nutrition (TPN) has been completed. The frequency of administration depends on the schedule of HPN. It varies between twice per week and once daily. The duration of TauroSept® administration in this trial will be 12 months.

Device: TauroSept®

Saline solution 0.9%

PLACEBO COMPARATOR

5 ml of saline will be instilled into the catheter (CVAD) each time after total parenteral nutrition (TPN) has been completed. The frequency of administration depends on the schedule of HPN. It varies between twice per week and once daily. The duration of saline administration in this trial will be 12 months.

Device: TauroSept®

Interventions

TauroSept®DEVICE

5 ml of TauroSept® will be instilled into the catheter (CVAD) each time after total parenteral nutrition (TPN) has been completed. The frequency of administration depends on the schedule of HPN. It varies between twice per week and once daily. The duration of TauroSept® administration in this trial will be 12 months.

Also known as: Taurolidine 2%
Saline solution 0.9%TauroSept®

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Benign underlying disease leading to long-term intestinal failure who will receive HPN and/or fluids (saline and/or glucose) at least 2 times /week over a subcutaneously tunnelled single-lumen Central Venous Catheter (CVC) (Hickman/Broviac or subcutaneous port) for at least one year
  • Patient receives a new single lumen central vascular access device for HPN (new patient starting HPN or patient already on HPN) allocation to Group I = new catheter group\] or
  • 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:

  • cannot be expected to comply with the trial plan (substance abuse, mental condition)
  • has significant cardiovascular disease such as unstable angina, 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 taurolidine 2% or saline solution 0.9% and/or their excipients.
  • is pregnant, lactating, or nursing.
  • has a current bloodstream infection
  • has any clinically significant abnormalities in blood coagulation requiring intervention
  • has received thrombolytic therapy in the 6 weeks prior to insertion (aspirin 80-325 mg daily is acceptable).
  • has received an investigational drug within 30 days of trial entry
  • has an antibiotic coated, silver impregnated or antimicrobial cuff catheter
  • has received a Taurolidine lock previously
  • has compromised skin integrity, including any infection at the insertion site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University Hospital Copenhagen Rigshospitalet

Copenhagen, 2100, Denmark

Location

University Clinic Münster

Münster, 48149, Germany

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

University of Bologna Center for Chronic Intestinal Failure Department of Gastroenterology and Internal Medicine

Bologna, 40138, Italy

Location

Department of Gastroenterology and Hepatology clinical ward

Nijmegen, 6500 HB, Netherlands

Location

St Mark's Hospital

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

University College Hospital

London, NW1 2PG, United Kingdom

Location

Related Publications (3)

  • Bisseling TM, Willems MC, Versleijen MW, Hendriks JC, Vissers RK, Wanten GJ. Taurolidine lock is highly effective in preventing catheter-related bloodstream infections in patients on home parenteral nutrition: a heparin-controlled prospective trial. Clin Nutr. 2010 Aug;29(4):464-8. doi: 10.1016/j.clnu.2009.12.005. Epub 2010 Jan 12.

    PMID: 20061070RESULT

  • Wouters Y, Theilla M, Singer P, Tribler S, Jeppesen PB, Pironi L, Vinter-Jensen L, Rasmussen HH, Rahman F, Wanten GJA. Randomised clinical trial: 2% taurolidine versus 0.9% saline locking in patients on home parenteral nutrition. Aliment Pharmacol Ther. 2018 Aug;48(4):410-422. doi: 10.1111/apt.14904. Epub 2018 Jul 5.

    PMID: 29978597DERIVED

  • 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: 29722835DERIVED

Study Design

Study Type
interventional
Phase
not applicable
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
MD, PhD, MSc

Study Record Dates

First Submitted

March 5, 2013

First Posted

April 8, 2013

Study Start

June 1, 2013

Primary Completion

September 1, 2016

Study Completion

November 1, 2016

Last Updated

December 6, 2016

Record last verified: 2016-12

Locations

IL(1)DK(1)IT(1)GB(2)DE(1)NL(1)