Effect of Infusion Set Replacement Intervals on Central Line-associated Bloodstream Infection in Adult Intensive Care Unit: a Multicenter Randomised Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,240
- Locations
- 1
- Primary Endpoint
- Central-line associated bloodstream infections (CLABSI) rates
Study Overview
Brief Summary
This study aimed to evaluate the efficacy of 24-hour versus 96-hour infusion set replacement to prevent central line-associated bloodstream infection (CLABSI) in critically ill adults with central venous access devices.
Detailed Description
Up to 70% of patients in acute care hospitals need a central venous access, and the latter is also widely used in other clinical settings. However, the central venous access usually remains associated with increased infection risks, which can be severe and even lethal.
Most contemporary guidelines recommend infusion set replacement every 4 days with the CDC in US recommending replacement "no more frequently than 96 hours, but at least every 7 days". However, the National Health Commission of the People's Republic of China recommend infusion set replacement every 24 hours in 2021. The previous evidence from neonate were in favor of the administration set changes of every 24 hours, compared with the longer time interval. However, it is unclear whether this conclusion applied to adult critically ill patients in ICU.
The purpose of the current study is therefore to compare the effectiveness of 24-hour versus 96-hours infusion set replacement to prevent central line-associated bloodstream infection (CLABSI) in critically ill adults with central venous access devices.
This study is a multicenter, single-blind randomized clinical trial designed to investigate the efficacy of the 24-hour versus 96-hours infusion set replacement to prevent central line-associated bloodstream infection (CLABSI) in critically ill adults with central venous access devices. The trial will enroll up to 1240 participant. The primary endpoint for this trial is the CLABSI rate. Mortality rate is a key secondary endpoint for the trial.
Specific Aims
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years or older
- •Able to provide informed consent
- •Expected length of stay (LOS) > 96 hours in intensive care unit (ICU)
- •Need for treatment with central venous access device
- •The central venous access device is expected to remain in place for at least 96 hours, with infusion set attached
Exclusion Criteria
- •Those who with a bloodstream infection within the previous 48 hours after ICU admission
- •Those who have their vascular access device actually removed within 96 hours after ICU admission
- •Those who have participated in other clinical studies within the 2 months
Arms & Interventions
24-hour
Every 24-hour infusion set replacement
Intervention: Infusion set replacement intervals (Procedure)
96-hour
Every 96-hour infusion set replacement
Intervention: Infusion set replacement intervals (Procedure)
Outcomes
Primary Outcomes
Central-line associated bloodstream infections (CLABSI) rates
Time Frame: Day 28
i) the catheter was in place for at least 48 hours prior to onset of sepsis, and/or ii) there was microbiologic growth (bacteria and/or fungi) of at least 15 colony forming units (CFU) on the CVC tip identical to a positive blood culture sample, and/or iii) the difference in time to positivity between a central and a peripheral drawn blood culture was more than 2 hours
Secondary Outcomes
- Hospital length of stay(Day 28)
- All-cause bloodstream infection rates(Day 28)
- Colonisation of vascular access device(Day 4)
- In-hospital all-cause mortality(Day 28)
- The cumulative time of catheter in situ(Day 28)
- The number of infusion sets used per patient(Day 28)
- Catheter-related bloodstream infection (CRBSI) rates(Day 28)
- The costs of consumables for doing all infusion set replacement procedures per patient(Day 28)
- ICU length of stay(Day 28)
- 28-day all-cause mortality(Day 28)
- Colonisation of infusion set(Day 4)
- ICU all-cause mortality(Day 28)
- The cumulative staff time for doing all infusion set replacement procedures per patient(Day 28)