Infusion Set Replacement Intervals for Critically Ill Patients
NCT ID: NCT05359601
Last Updated: 2023-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
1240 participants
INTERVENTIONAL
2022-05-15
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
24-hour
Every 24-hour infusion set replacement
Infusion set replacement intervals
24-hour or 96-hour infusion set replacement intervals
96-hour
Every 96-hour infusion set replacement
Infusion set replacement intervals
24-hour or 96-hour infusion set replacement intervals
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Infusion set replacement intervals
24-hour or 96-hour infusion set replacement intervals
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zhongnan Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Fen Hu
Role: CONTACT
Phone: +86-13971218086
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Bo Hu, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BHu
Identifier Type: -
Identifier Source: org_study_id