Infectious Diseases and Therapy (Mar 2024)

Effect of Infusion Set Replacement Intervals on Central Line-Associated Bloodstream Infection in the Intensive Care Unit: Study Protocol of the INSPIRATION Study

  • Dandan Xu,
  • Chang Hu,
  • Jie Xiong,
  • Haiyan Huang,
  • Shasha Wang,
  • Xinbo Ding,
  • Junying Zhou,
  • Juan Deng,
  • Chunling Guo,
  • Miqi Li,
  • Ting You,
  • Wei Cheng,
  • Bo Li,
  • Xiaoqin Tang,
  • Xiaohong Li,
  • Hongmei Li,
  • Jin Li,
  • Jing Ma,
  • Meng Xiao,
  • Xing Fu,
  • Huilin Li,
  • Zhiyong Peng,
  • Bo Hu,
  • Fen Hu,
  • On behalf of the INSPIRATION Study group

DOI
https://doi.org/10.1007/s40121-024-00953-y
Journal volume & issue
Vol. 13, no. 4
pp. 941 – 951

Abstract

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Abstract Introduction The replacement intervals for infusion sets may differ among healthcare institutions, which may have an impact on the occurrence of central line-associated bloodstream infections (CLABSI). Nevertheless, there exists a limited amount of high-quality evidence available to assist clinicians in determining the most suitable replacement intervals for infusion sets. Therefore, the objective of this trial is to compare the efficacy of 24-h and 96-h replacement intervals for infusion sets on CLABSI among critically ill adults who have central venous access devices. Methods This is a multicenter, parallel-group randomized controlled trial that will investigate the effect of infusion set replacement intervals on CLABSI in adult patients admitted to intensive care units (ICUs). The study will enroll 1240 participants who meet the inclusion criteria, which includes being 18 years or older, expected to stay in the ICU for longer than 96 h, and in need of central venous access. Participants will be randomly assigned to either a control group receiving a 96-h replacement interval or a treatment group receiving a 24-h replacement interval. Planned Outcome The primary outcome of this trial is the rate of CLABSI within 28 days after randomization. Conclusion This is the first randomized controlled trial to investigate the effects of infusion set replacement at 24-h and 96-h intervals on CLABSI in ICU patients. Trial Registration ClinicalTrials.gov identifier, NCT05359601.

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