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.
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 1. To demonstrate the efficacy of 24-hour infusion set replacement to reduce the rate of CLABSI, compared with 96-hours infusion set replacement. 2. To demonstrate the efficacy of 24-hour infusion set replacement to reduce the rate of CRBSI, all-cause bloodstream infection, and mortality, compared with 96-hours infusion set replacement.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,240
24-hour or 96-hour infusion set replacement intervals
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
RECRUITINGCentral-line associated bloodstream infections (CLABSI) rates
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
Time frame: Day 28
Catheter-related bloodstream infection (CRBSI) rates
A bacteraemia or fungaemia (with clinical manifestations of infection and no other identifiable source) and at least one positive blood culture from a peripheral vein, plus matching organism(s) found on the catheter tip (\>15 CFUs on semiquantitative culture); or, two blood cultures (one from catheter, one from peripheral vein) with matching organism(s) that met the criteria for differential time to positivity (growth of catheter-drawn blood at least 2 h before growth from a peripheral vein blood culture)
Time frame: Day 28
All-cause bloodstream infection rates
All-cause bloodstream infection
Time frame: Day 28
Colonisation of vascular access device
Semiquantitative method ('Maki roll'), cutoff ≥15 cfu/catheter
Time frame: Day 4
Colonisation of infusion set
Quantitative (broth dilution) method, cutoff ≥1000 cfu/ml
Time frame: Day 4
ICU all-cause mortality
Number of patients who were confirmed to be dead in ICU from enrollment onto the study
Time frame: Day 28
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In-hospital all-cause mortality
Number of patients who were confirmed to be dead in hospital from enrollment onto the study
Time frame: Day 28
28-day all-cause mortality
Number of patients who were confirmed to be dead within 28-day from enrollment onto the study
Time frame: Day 28
ICU length of stay
Length of intensive care unit stay
Time frame: Day 28
Hospital length of stay
Length of hospital stay
Time frame: Day 28
The cumulative time of catheter in situ
The cumulative time of catheter in situ
Time frame: Day 28
The number of infusion sets used per patient
The cumulative number of individual infusion sets used per patient
Time frame: Day 28
The costs of consumables for doing all infusion set replacement procedures per patient
The cumulative costs of consumables for doing all infusion set replacement procedures per patient
Time frame: Day 28
The cumulative staff time for doing all infusion set replacement procedures per patient
The cumulative staff time for doing all infusion set replacement procedures per patient
Time frame: Day 28