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Taurolidine Lock in Long Term Parenteral Nutrition

NCT ID: NCT02009189

Last Updated: 2013-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Home Parenteral Nutrition Central Venous Catheter

Keywords

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home parenteral nutrition central venous catheter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

Saline flush

Group Type PLACEBO_COMPARATOR

2% Taurolidine Lock

Intervention Type DRUG

Catheter lock with 2% Taurolidine

1.35% Taurolidine

Intervention Type DRUG

Catheter lock with 1.35% Taurolidine + citrate

2% Taurolidine lock

Catheter lock with 2% Taurolidine

Group Type ACTIVE_COMPARATOR

2% Taurolidine Lock

Intervention Type DRUG

Catheter lock with 2% Taurolidine

1.35% Taurolidine

Intervention Type DRUG

Catheter lock with 1.35% Taurolidine + citrate

1.35% Taurolidine with citrate

Catheter lock with 1.35% Taurolidine + citrate

Group Type ACTIVE_COMPARATOR

2% Taurolidine Lock

Intervention Type DRUG

Catheter lock with 2% Taurolidine

1.35% Taurolidine

Intervention Type DRUG

Catheter lock with 1.35% Taurolidine + citrate

Interventions

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2% Taurolidine Lock

Catheter lock with 2% Taurolidine

Intervention Type DRUG

1.35% Taurolidine

Catheter lock with 1.35% Taurolidine + citrate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanley Dudrick's Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Stanislaw Klek

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stanislaw Klek, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Stanley Dudrick's Memorial Hospital

Locations

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Stanley Dudrick's Memorial Hospital

Skawina, , Poland

Site Status

Countries

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Poland

References

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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.

Reference Type BACKGROUND
PMID: 19464090 (View on PubMed)

Other Identifiers

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Tauro-1

Identifier Type: -

Identifier Source: org_study_id