NCT02009189

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

November 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

1 year

First QC Date

December 8, 2013

Last Update Submit

December 10, 2013

Conditions

Home Parenteral NutritionCentral Venous Catheter

Keywords

home parenteral nutritioncentral venous catheter

Outcome Measures

Primary Outcomes (1)

  • Number of CVC infections

    Number of central venous catheter infections

    12 months

Study Arms (3)

Control

PLACEBO COMPARATOR

Saline flush

Drug: 2% Taurolidine LockDrug: 1.35% Taurolidine

2% Taurolidine lock

ACTIVE COMPARATOR

Catheter lock with 2% Taurolidine

Drug: 2% Taurolidine LockDrug: 1.35% Taurolidine

1.35% Taurolidine with citrate

ACTIVE COMPARATOR

Catheter lock with 1.35% Taurolidine + citrate

Drug: 2% Taurolidine LockDrug: 1.35% Taurolidine

Interventions

2% Taurolidine LockDRUG

Catheter lock with 2% Taurolidine

1.35% Taurolidine with citrate2% Taurolidine lockControl
1.35% TaurolidineDRUG

Catheter lock with 1.35% Taurolidine + citrate

1.35% Taurolidine with citrate2% Taurolidine lockControl

Eligibility Criteria

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

You may qualify if:

  • home parenteral nutrition for at least months before enrollment
  • presence of central venous cathter

You may not qualify if:

  • home nutrition \< 12 months
  • catheter in peripheral vein

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanley Dudrick's Memorial Hospital

Skawina, 32-050, Poland

Location

Related Publications (1)

  • 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.

    PMID: 19464090BACKGROUND

MeSH Terms

Interventions

taurolidine

Study Officials

  • Stanislaw Klek, Assoc Prof

    Stanley Dudrick's Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

December 8, 2013

First Posted

December 11, 2013

Study Start

November 1, 2012

Primary Completion

November 1, 2013

Study Completion

December 1, 2013

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations

PL(1)