---
title: Infusion Set Replacement Intervals for Critically Ill Patients
nct_id: NCT05359601
overall_status: RECRUITING
phase: NA
sponsor: Zhongnan Hospital
study_type: INTERVENTIONAL
primary_condition: Critical Illness
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05359601.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05359601"
ct_last_update_post_date: 2023-12-29
last_seen_at: "2026-05-12T06:28:55.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Infusion Set Replacement Intervals for Critically Ill Patients

**Official Title:** Effect of Infusion Set Replacement Intervals on Central Line-associated Bloodstream Infection in Adult Intensive Care Unit: a Multicenter Randomised Clinical Trial

**NCT ID:** [NCT05359601](https://clinicaltrials.gov/study/NCT05359601)

## Key Facts

- **Status:** RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 1240
- **Lead Sponsor:** Zhongnan Hospital
- **Conditions:** Critical Illness
- **Start Date:** 2022-05-15
- **Completion Date:** 2026-06-30
- **CT.gov Last Update:** 2023-12-29

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **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
```

## Arms

- **24-hour** (EXPERIMENTAL) — Every 24-hour infusion set replacement
- **96-hour** (PLACEBO_COMPARATOR) — Every 96-hour infusion set replacement

## Interventions

- **Infusion set replacement intervals** (PROCEDURE) — 24-hour or 96-hour infusion set replacement intervals

## Primary Outcomes

- **Central-line associated bloodstream infections (CLABSI) rates** _(time frame: 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 Outcomes

- **Catheter-related bloodstream infection (CRBSI) rates** _(time frame: Day 28)_
- **All-cause bloodstream infection rates** _(time frame: Day 28)_
- **Colonisation of vascular access device** _(time frame: Day 4)_
- **Colonisation of infusion set** _(time frame: Day 4)_
- **ICU all-cause mortality** _(time frame: Day 28)_
- **In-hospital all-cause mortality** _(time frame: Day 28)_
- **28-day all-cause mortality** _(time frame: Day 28)_
- **ICU length of stay** _(time frame: Day 28)_
- **Hospital length of stay** _(time frame: Day 28)_
- **The cumulative time of catheter in situ** _(time frame: Day 28)_
- **The number of infusion sets used per patient** _(time frame: Day 28)_
- **The costs of consumables for doing all infusion set replacement procedures per patient** _(time frame: Day 28)_
- **The cumulative staff time for doing all infusion set replacement procedures per patient** _(time frame: Day 28)_

## Locations (1)

- Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.zhongnan hospital of wuhan university|wuhan|hubei|china` — added _(2026-05-12)_

---

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