Recipient organisationUCL Institute of Child Health
Funding£1.7M
PeriodMar 2010 — Apr 2015
In plain English
AI plain-English summary
Every year, around 1,200 children in UK paediatric intensive care units will be randomly assigned to receive one of three types of central venous catheter—standard, antibiotic-impregnated, or heparin-bonded—to see which best prevents bloodstream infections. These catheters are essential for delivering drugs and fluids to critically ill children, but they also act as a direct highway for bacteria into the bloodstream. Hospital-acquired bloodstream infections in children are serious, prolonging stays, increasing antibiotic use, and raising mortality risk. Despite this, no large-scale trial has directly compared these three catheter types in children. If the trial shows that antibiotic-impregnated or heparin-bonded catheters significantly reduce infection rates, the NHS could adopt them as standard practice. That would mean fewer children suffering preventable infections, shorter intensive care stays, and reduced antibiotic use—slowing the spread of resistance. The trial also includes a cost-effectiveness analysis, so funders will know whether the extra upfront cost of these specialised catheters is offset by savings from fewer infections and shorter hospital stays. The results could quietly reshape a routine but high-stakes medical device choice in every paediatric intensive care unit in the UK.
View original technical description
The trial is a pragmatic, Phas III, 3-arm randomised controlled clinical trial. Treatment allocation cannot be blinded to the clinician responsible for randomising a patient and inserting the central venous catheter (CVC) but will be concealed from patients, their parents and PICU personnel responsible for their care. Population: The study population is 1200 children less than 16 years of age admitted to PICU, who require insertion of a polyurethane CVC for at least 3 days, and who weigh more than 3 kg. We will recruit children from two broad clinical groups: children admitted as planned surgical admissions (about one-third of all admissions) and children admitted as an emergency from the same or another hospital. Approximately 40% of PICU admissions are expected to be eligible. Recruitment targets will be reached if 1 in 4 of these patients are enrolled. As this study involves treatment in an emergency situation, we will be requesting ethical approval for a deferred consent process for children admitted as an emergency. The line can then be inserted without any delay and consent/assent will be sought at 48 hours post randomisation, or once the patient's condition allows. The study will involve 10 UK Paediatric Intensive Care Units (PICUs). Study Duration: Patient follow-up until 48 hours after removal of the randomised CVC will be by the research nurse. Follow-up at 6 months will be ascertained from routine administrative data. Description of Agent/ Intervention: We will randomly allocate children to a standard polyurethane CVC, antibiotic impregnated CVC (minocycline and rifampicin), or heparin bonded polyurethane CVC. in a ratio of 1:1:1. Objectives: Primary: To determine the effectiveness of heparin bonded or antibiotic impregnated CVCs compared with standard CVCs for preventing hospital acquired blood stream infection. Secondary Objectives include: Cost effectiveness, effectiveness of type of CVC in 3-way comparison for preventing hospital acquired blood stream infection, effect of type of CVC on clinical measures of care (duration of CVC insertion, antibiotic use, and stay), mortality at 30 days and adverse events on pathogen selection, antibiotic resistance, clinical evidence of CVC thrombosis, and thrombocytopenia.
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