Taurolidine Lock in Long Term Parenteral Nutrition

Stanley Dudrick's Memorial Hospital

Status and phase: Completed; Phase 4

Conditions: Home Parenteral Nutrition; Central Venous Catheter

Treatments: Drug: 1.35% Taurolidine; Drug: 2% Taurolidine Lock

Study type: Interventional

Funder types: Other

Identifiers

NCT02009189

Tauro-1

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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30 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Saline flush

Treatment:

Drug: 1.35% Taurolidine

Drug: 2% Taurolidine Lock

2% Taurolidine lock

Active Comparator group

Description:

Catheter lock with 2% Taurolidine

Treatment:

Drug: 1.35% Taurolidine

Drug: 2% Taurolidine Lock

1.35% Taurolidine with citrate

Active Comparator group

Description:

Catheter lock with 1.35% Taurolidine + citrate

Treatment:

Drug: 1.35% Taurolidine

Drug: 2% Taurolidine Lock