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 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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness
• Intervention / Treatment: Procedure: Infusion set replacement intervals

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.

• Study Type: Interventional
• Enrollment (Estimated): 1240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bo Hu, MD; Phone Number: +86-18062603223; Email: hobbier1979@163.com
• Study Contact Backup: Name: Fen Hu; Phone Number: +86-13971218086

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430070
      • Recruiting
      • Zhongnan Hospital of Wuhan University
      • Contact: Bo Hu, MD; Phone Number: +86-18062603223; Email: hobbier1979@163.com
      • Principal Investigator: Bo Hu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 24-hour; Every 24-hour infusion set replacement	Procedure: Infusion set replacement intervals; 24-hour or 96-hour infusion set replacement intervals
Placebo Comparator: 96-hour; Every 96-hour infusion set replacement	Procedure: Infusion set replacement intervals; 24-hour or 96-hour infusion set replacement intervals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zhongnan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Intensive care unit; Critical Illness; CLABSI; Infusion set
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: BHu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No