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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 24-hour | Experimental | Every 24-hour infusion set replacement |
|
| 96-hour | Placebo Comparator | Every 96-hour infusion set replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infusion set replacement intervals | Procedure | 24-hour or 96-hour infusion set replacement intervals |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo Hu, MD | Contact | +86-18062603223 | hobbier1979@163.com | |
| Fen Hu | Contact | +86-13971218086 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan Hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430070 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38483776 | Derived | Xu D, Hu C, Xiong J, Huang H, Wang S, Ding X, Zhou J, Deng J, Guo C, Li M, You T, Cheng W, Li B, Tang X, Li X, Li H, Li J, Ma J, Xiao M, Fu X, Li H, Peng Z, Hu B, Hu F; INSPIRATION Study group. Effect of Infusion Set Replacement Intervals on Central Line-Associated Bloodstream Infection in the Intensive Care Unit: Study Protocol of the INSPIRATION Study. Infect Dis Ther. 2024 Apr;13(4):941-951. doi: 10.1007/s40121-024-00953-y. Epub 2024 Mar 14. |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |