A Feasibility Pilot Randomised Control Trial to Compare Failure Rates between Peripherally Inserted Central Catheter (PICC) and Anti-infective Peripherally Inserted Central Catheter (PICC) lines in patients that receive Total Parenteral Nutrition (TPN)

Phase 4

Active, not recruiting

• Conditions: Catheter failure in patients receiving total parenteral nutrition; central vascular access devices; Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

• Registration Number: ACTRN12614000965606
• Lead Sponsor: Sir Charles Gairdner Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients would be included in this study if they:
* are English speaking, competent, and provide informed consent to participation;
* are aged 18 years and older;
* are haemodynamically stable;
* require TPN;
* are suitable for the insertion of a PICC line

Exclusion Criteria

Patients would be excluded from the study if they:
* are unable to give consent or decline consent;
* are pregnant;
* are allergic to the anti-infective catheter or its components;
* have an existing identified CLABSI.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary aim of this study is to determine in patients who receive TPN if there is a difference in the failure rates of an anti-infective PICC line, and a standard PICC line. Catheter failure is a composite endpoint including any line complication resulting in removal or exchange of the line. Failure then may include failure as a result of infection (CLABSI), catheter blockage necessitating removal or exchange, catheter associated venous thromboembolism , catheter dislodgement, and phlebitis[ From catheter insertion (time zero), until catheter removal or as no longer needed or patient death or 48hours after patient discharge]

Secondary Outcome Measures

Name	Time	Method
The difference in the economic costs between the anti-infective PICC and the standard PICC line. This will be assessed by hospital costs, nurse costs, medical consultant costs.[Time zero will be catheter insertion, time of event will be catheter failure, and censor time will be patient discharge, catheter removal as no longer needed or patient death]