Critical Illness
Conditions
Keywords
Infusion set, CLABSI, Intensive care unit, Critical Illness
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.
Interventions
PROCEDUREInfusion set replacement intervals
24-hour or 96-hour infusion set replacement intervals
Sponsors
Zhongnan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central-line associated bloodstream infections (CLABSI) rates | Day 28 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause bloodstream infection rates | Day 28 | All-cause bloodstream infection |
| Colonisation of vascular access device | Day 4 | Semiquantitative method ('Maki roll'), cutoff ≥15 cfu/catheter |
| Colonisation of infusion set | Day 4 | Quantitative (broth dilution) method, cutoff ≥1000 cfu/ml |
| ICU all-cause mortality | Day 28 | Number of patients who were confirmed to be dead in ICU from enrollment onto the study |
| In-hospital all-cause mortality | Day 28 | Number of patients who were confirmed to be dead in hospital from enrollment onto the study |
| 28-day all-cause mortality | Day 28 | Number of patients who were confirmed to be dead within 28-day from enrollment onto the study |
| Catheter-related bloodstream infection (CRBSI) rates | Day 28 | 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) |
| Hospital length of stay | Day 28 | Length of hospital stay |
| The cumulative time of catheter in situ | Day 28 | The cumulative time of catheter in situ |
| The number of infusion sets used per patient | Day 28 | The cumulative number of individual infusion sets used per patient |
| The costs of consumables for doing all infusion set replacement procedures per patient | Day 28 | The cumulative costs of consumables for doing all infusion set replacement procedures per patient |
| The cumulative staff time for doing all infusion set replacement procedures per patient | Day 28 | The cumulative staff time for doing all infusion set replacement procedures per patient |
| ICU length of stay | Day 28 | Length of intensive care unit stay |
Countries
China
Contacts
Primary ContactBo Hu, MD
Backup ContactFen Hu
Outcome results
None listed