Skip to main content
Clinical Trials/NCT02009189
NCT02009189CompletedPhase 4

The Value of Taurolidine Lock in Long Term Parenteral Nutrition

Stanley Dudrick's Memorial Hospital1 site in 1 country30 target enrollmentStarted: November 2012Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Number of CVC infections

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • home nutrition < 12 months
  • catheter in peripheral vein

Arms & Interventions

Control

Placebo Comparator

Saline flush

Intervention: 2% Taurolidine Lock (Drug)

Control

Placebo Comparator

Saline flush

Intervention: 1.35% Taurolidine (Drug)

2% Taurolidine lock

Active Comparator

Catheter lock with 2% Taurolidine

Intervention: 2% Taurolidine Lock (Drug)

2% Taurolidine lock

Active Comparator

Catheter lock with 2% Taurolidine

Intervention: 1.35% Taurolidine (Drug)

1.35% Taurolidine with citrate

Active Comparator

Catheter lock with 1.35% Taurolidine + citrate

Intervention: 2% Taurolidine Lock (Drug)

1.35% Taurolidine with citrate

Active Comparator

Catheter lock with 1.35% Taurolidine + citrate

Intervention: 1.35% Taurolidine (Drug)

Outcomes

Primary Outcomes

Number of CVC infections

Time Frame: 12 months

Number of central venous catheter infections

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Stanley Dudrick's Memorial Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Stanislaw Klek

Assoc. Prof.

Stanley Dudrick's Memorial Hospital

Study Sites (1)

Loading locations...

Similar Trials