Clinical trial NCT05359601: Infusion Set Replacement Intervals for Critically Ill Patients
Official title: Effect of Infusion Set Replacement Intervals on Central Line-associated Bloodstream Infection in Adult Intensive Care Unit: a Multicenter Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness
Keywords: Infusion set
CLABSI
Intensive care unit
Critical Illness
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 1240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

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

Primary outcomes:
measure: Central-line associated bloodstream infections (CLABSI) rates
timeFrame: Day 28
Secondary outcomes:
measure: Catheter-related bloodstream infection (CRBSI) rates
timeFrame: Day 28
measure: All-cause bloodstream infection rates
timeFrame: Day 28
measure: Colonisation of vascular access device
timeFrame: Day 4
measure: Colonisation of infusion set
timeFrame: Day 4
measure: ICU all-cause mortality
timeFrame: Day 28
measure: In-hospital all-cause mortality
timeFrame: Day 28
measure: 28-day all-cause mortality
timeFrame: Day 28
measure: ICU length of stay
timeFrame: Day 28
measure: Hospital length of stay
timeFrame: Day 28
measure: The cumulative time of catheter in situ
timeFrame: Day 28
measure: The number of infusion sets used per patient
timeFrame: Day 28
measure: The costs of consumables for doing all infusion set replacement procedures per patient
timeFrame: Day 28
measure: The cumulative staff time for doing all infusion set replacement procedures per patient
timeFrame: Day 28
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
References: