Infusion Set Replacement Intervals for Critically Ill Patients

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05359601
• Other study ID #: BHu
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: December 2023
• Source: Zhongnan Hospital
• Contact: Bo Hu, MD
• Phone: +86-18062603223
• Email: hobbier1979[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1240
• Est. completion date: June 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

Procedure:
• Infusion set replacement intervals
24-hour or 96-hour infusion set replacement intervals

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central-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	Day 28
Secondary	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)	Day 28
Secondary	All-cause bloodstream infection rates	All-cause bloodstream infection	Day 28
Secondary	Colonisation of vascular access device	Semiquantitative method ('Maki roll'), cutoff =15 cfu/catheter	Day 4
Secondary	Colonisation of infusion set	Quantitative (broth dilution) method, cutoff =1000 cfu/ml	Day 4
Secondary	ICU all-cause mortality	Number of patients who were confirmed to be dead in ICU from enrollment onto the study	Day 28
Secondary	In-hospital all-cause mortality	Number of patients who were confirmed to be dead in hospital from enrollment onto the study	Day 28
Secondary	28-day all-cause mortality	Number of patients who were confirmed to be dead within 28-day from enrollment onto the study	Day 28
Secondary	ICU length of stay	Length of intensive care unit stay	Day 28
Secondary	Hospital length of stay	Length of hospital stay	Day 28
Secondary	The cumulative time of catheter in situ	The cumulative time of catheter in situ	Day 28
Secondary	The number of infusion sets used per patient	The cumulative number of individual infusion sets used per patient	Day 28
Secondary	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	Day 28
Secondary	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	Day 28