NCT05359601

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,240

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
May 2022Jun 2026

First Submitted

Initial submission to the registry

March 28, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

May 15, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

December 29, 2023

Status Verified

December 1, 2023

Enrollment Period

3.6 years

First QC Date

March 28, 2022

Last Update Submit

December 28, 2023

Conditions

Critical Illness

Keywords

Infusion setCLABSIIntensive care unitCritical Illness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Catheter-related bloodstream infection (CRBSI) rates

    Day 28

  • All-cause bloodstream infection rates

    Day 28

  • Colonisation of vascular access device

    Day 4

  • Colonisation of infusion set

    Day 4

  • ICU all-cause mortality

    Day 28

  • +8 more secondary outcomes

Study Arms (2)

24-hour

EXPERIMENTAL

Every 24-hour infusion set replacement

Procedure: Infusion set replacement intervals

96-hour

PLACEBO COMPARATOR

Every 96-hour infusion set replacement

Procedure: Infusion set replacement intervals

Interventions

Infusion set replacement intervalsPROCEDURE

24-hour or 96-hour infusion set replacement intervals

24-hour96-hour

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430070, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38483776DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Bo Hu, MD

CONTACT

+86-18062603223hobbier1979@163.com

Fen Hu

CONTACT

+86-13971218086

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2022

First Posted

May 4, 2022

Study Start

May 15, 2022

Primary Completion

December 30, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

December 29, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)