Comparing infusion set replacement intervals for critically ill patients

Effect of Infusion Set Replacement Intervals on Central Line-associated Bloodstream Infection in Adult Intensive Care Unit: a Multicenter Randomised Clinical Trial

This study is testing if changing infusion sets every 24 hours instead of every 96 hours can help prevent infections in critically ill adults with central lines.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1240 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhongnan Hospital (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT05359601 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of replacing infusion sets every 24 hours versus every 96 hours to prevent central line-associated bloodstream infections (CLABSI) in critically ill adults with central venous access devices. It is a multicenter, single-blind randomized clinical trial that aims to enroll up to 1240 participants. The primary endpoint is the rate of CLABSI, while mortality rate is also assessed as a secondary outcome. The study addresses a significant gap in current guidelines regarding infusion set replacement intervals in adult ICU patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 years or older who are expected to stay in the ICU for more than 96 hours and require a central venous access device.

Not a fit: Patients who have a bloodstream infection within 48 hours of ICU admission or those whose vascular access device is removed within 96 hours may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved infection control practices and better outcomes for critically ill patients requiring central venous access.

How similar studies have performed: Previous studies in neonates have shown benefits from more frequent infusion set changes, but this approach in adult critically ill patients is less established.

Eligibility criteria

Inclusion Criteria:

1. Age 18 years or older
2. Able to provide informed consent
3. Expected length of stay (LOS) \> 96 hours in intensive care unit (ICU)
4. Need for treatment with central venous access device
5. The central venous access device is expected to remain in place for at least 96 hours, with infusion set attached

Exclusion Criteria:

1. Those who with a bloodstream infection within the previous 48 hours after ICU admission
2. Those who have their vascular access device actually removed within 96 hours after ICU admission
3. Those who have participated in other clinical studies within the 2 months

Where this trial is running

Wuhan, Hubei

• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Bo Hu, MD

Conditions Critical Illness; Infusion set; CLABSI; Intensive care unit