Infusion Set Replacement Intervals for Critically Ill Patients

Study Overview
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Brief Summary
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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
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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 To demonstrate the efficacy of 24-hour infusion set replacement to reduce the rate of CLABSI, compared with 96-hours infusion set replacement. 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.

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

Conditions
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Critical Illness

Intervention / Treatment
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* Procedure: Infusion set replacement intervals


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 24-hour<br>Every 24-hour infusion set replacement | Procedure: Infusion set replacement intervals<br>* 24-hour or 96-hour infusion set replacement intervals<br>|
| Placebo Comparator: 96-hour<br>Every 96-hour infusion set replacement | Procedure: Infusion set replacement intervals<br>* 24-hour or 96-hour infusion set replacement intervals<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infusion set, CLABSI, Intensive care unit, Critical Illness