ActivePhase 4ACTRN12614000965606

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)


Sponsor

Sir Charles Gairdner Hospital

Enrollment

60 participants

Start Date

Jul 8, 2015

Study Type

Interventional

Conditions

Summary

This project will address a significant problem in healthcare which is to provide safe, effective and reliable vascular access when commencing a patient on Total Parenteral Nutrition (TPN). TPN is used in patients where the gastro-intestinal tract cannot be used for the ingestion, digestion and absorption of essential nutrition. Two types of central venous access devices (CVADs) are central venous catheters (CVCs) which are inserted centrally into the veins on the neck and peripherally inserted central catheters (PICCs) which are inserted via veins in the arms. PICCs can be associated with central line associated blood stream infection (CLABSI), thrombotic complications (thrombosis) and mechanical complications (catheter occlusion, phlebitis). These complications impact on the cost of care, and have the potential to be a life-threatening adverse event. To help combat this problem PICC lines have been developed that are coated with antiseptics or antibiotics, referred to as anti-infective lines. There are few comparison studies that have analysed the safety and costs of the lines by comparing anti-infective PICCs and standard PICCs in patients that receive TPN. Despite this gap in research, there is an increased use of the PICC line based on perceived time benefit, lower cost and fewer mechanical complications, where there is a lack of scientific evidence to support this choice. The main aim of this study is to determine if there is a difference in the failure rates and costs between the patients who receive TPN via an anti-infective PICC line and a standard PICC line. This feasibility pilot study will be a carried out a single centre. Participants will be patients requiring the insertion of a CVAD for delivery of TPN during the study period that meet the inclusion criteria and sign consent. They will be randomised into one of two groups, we aim to recruit 30 patients per group: * group 1 (Anti-infective PICC) * group 2 (Standard PICC) It is envisaged that findings from this study will provide a foundation for a larger study to explore the failure rates of PICC and anti-infective PICC lines used for delivery of parenteral nutrition, and to develop recommendations for the choice of PICC in patients receiving TPN.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria6

  • 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 Criteria5

  • 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.

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Interventions

Two types of central venous access devices (CVADs) are central venous catheters (CVCs) which are inserted centrally into the veins on the neck and peripherally inserted central catheters (PICCs) which

Two types of central venous access devices (CVADs) are central venous catheters (CVCs) which are inserted centrally into the veins on the neck and peripherally inserted central catheters (PICCs) which are inserted via veins in the arms. PICC lines have been developed that are coated with antiseptics or antibiotics, referred to as anti-infective lines. The frequency and duration of the intervention device is from catheter insertion (time zero), until catheter removal or as no longer needed or patient death or catheter failure. 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. All participants recruited will be randomised to one of two arms: * * group 1 (Anti-infective PICC) The Cook Spectrum'Registered Trademark' Minocycline+Rifampin Impregnated PICC * group 2 (Standard PICC) The Cook 'Registered Trademark'PICC


Locations(2)

Sir Charles Gairdner Hospital - Nedlands

WA, Australia

Fiona Stanley Hospital - Murdoch

WA, Australia

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ACTRN12614000965606