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Critical IllnessNCT05359601

Infusion Set Replacement Intervals for Critically Ill Patients

A study testing Infusion set replacement intervals in people with Critical Illness, run by Zhongnan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Critical Illness
What is being tested?
Infusion set replacement intervals
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,240 participants
Where
1 siteChina
Study dates
15 May 2022to 30 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Bo Hu, MD contact

+86-18062603223

hobbier1979@163.com

Fen Hu contact

+86-13971218086

China1 site, 1 recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430070

    Bo Hu, MD, +86-18062603223, hobbier1979@163.com

    Bo Hu, MD

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.
Being tested
Infusion set replacement intervals
Keywords
Infusion set, CLABSI, Intensive care unit, Critical Illness
Medical subject headings
Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Infusion set replacement intervalsProcedure or surgery

    24-hour or 96-hour infusion set replacement intervals

Study groups in NCT05359601
Study groupRoleWhat they receive
24-hourExperimentalEvery 24-hour infusion set replacement
Receives: Procedure: Infusion set replacement intervals
96-hourPlacebo comparatorEvery 96-hour infusion set replacement
Receives: Procedure: Infusion set replacement intervals

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Central-line associated bloodstream infections (CLABSI) rates

    1. 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

    Measured: Day 28

Secondary outcomes (13)

  1. 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)

    Measured: Day 28

  2. All-cause bloodstream infection rates

    All-cause bloodstream infection

    Measured: Day 28

  3. Colonisation of vascular access device

    Semiquantitative method ('Maki roll'), cutoff ≥15 cfu/catheter

    Measured: Day 4

  4. Colonisation of infusion set

    Quantitative (broth dilution) method, cutoff ≥1000 cfu/ml

    Measured: Day 4

  5. ICU all-cause mortality

    Number of patients who were confirmed to be dead in ICU from enrollment onto the study

    Measured: Day 28

  6. In-hospital all-cause mortality

    Number of patients who were confirmed to be dead in hospital from enrollment onto the study

    Measured: Day 28

  7. 28-day all-cause mortality

    Number of patients who were confirmed to be dead within 28-day from enrollment onto the study

    Measured: Day 28

  8. ICU length of stay

    Length of intensive care unit stay

    Measured: Day 28

  9. Hospital length of stay

    Length of hospital stay

    Measured: Day 28

  10. The cumulative time of catheter in situ

    The cumulative time of catheter in situ

    Measured: Day 28

  11. The number of infusion sets used per patient

    The cumulative number of individual infusion sets used per patient

    Measured: Day 28

  12. 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

    Measured: Day 28

  13. 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

    Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2022
  2. Study start15 May 2022
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05359601
Sponsor's protocol ID
BHu
Status last verified
Dec 2023
First submitted
28 Mar 2022
Last updated
29 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38483776

Questions about this trial

What is this clinical trial studying?

A study testing Infusion set replacement intervals in people with Critical Illness, run by Zhongnan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bo Hu, MD (+86-18062603223, hobbier1979@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Central-line associated bloodstream infections (CLABSI) rates (time frame: Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05359601, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.

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Clinical Trial NCT05359601 | AzTrials