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CompletedNCT07172711Updated Sep 15, 2025

Risk Factors for Catheter-Related Bloodstream Infections in Hospitalized Intestinal Failure Patients

An observational study in Catheter-related Bloodstream Infection and Intestinal Failure, sponsored by Jinling Hospital, China. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Jinling Hospital, China · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
321
Sex
All
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Study summary

This retrospective cohort study aims to identify risk factors for catheter-related bloodstream infections (CRBSIs) in hospitalized patients with intestinal failure (IF), including all subtypes (Types I-III). The study included 321 patients with 9,365 catheter-days. Multivariate logistic and Cox regression analyses were used to identify independent risk factors. Stratified analyses identified subtype-specific risks, and hospital stay length and health economic outcomes were assessed. The study highlights the need for subtype-tailored prevention strategies and closer metabolic and immune monitoring in hospitalized IF patients.

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Conditions studied

  • Catheter-related Bloodstream Infection
  • Intestinal Failure

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03

In context

Intestinal Failure

64 studies on the registry are indexed under Intestinal Failure; 17 are open to participants now.

This study's enrollment of 321 is above the median of 60 across 19 observational studies indexed under Intestinal Failure.

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Lead sponsor

Jinling Hospital, China is the lead sponsor of 131 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This single-center retrospective study enrolled 321 patients with intestinal failure admitted between 2021 and 2024. All included patients met the ESPEN 2023 diagnostic criteria for intestinal failure, defined as reduced intestinal function below the minimum necessary for absorption of macronutrients and/or water-electrolytes, thus requiring intravenous supplementation (IVS) to maintain health and/or growth. Patients were excluded if they met any of the following criteria: Catheter indwelling duration \<48 hours; Implanted catheter before admission; Complex components in PN difficult to quantify; Positive blood cultures with unclear CRBSI diagnosis; Alternative infection sources identified.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients meeting the ESPEN 2023 diagnostic criteria for intestinal failure.

Exclusion criteria

Exclusion Criteria:

  • Catheter indwelling duration \<48 hours; Implanted catheter before admission; Complex components in PN difficult to quantify; Positive blood cultures with unclear CRBSI diagnosis; Alternative infection sources identified.
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
321 participants (actual)
Patient registry
No

Groups and cohorts

  • CRBSIs

    Patients with intestinal failure who developed catheter-related bloodstream infection

  • Non-CRBSI

    Patients with intestinal failure who never developed catheter-related bloodstream infection

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What researchers measure

Primary outcomes

  1. incidence rate of catheter-related bloodstream infection

    frequency of catheter-related bloodstream infections occurring every 1,000 days

    Time frame: From catheter insertion until removal or discharge, assessed up to 24 months.

Secondary outcomes

  1. Proportion of patients with high calorie-to-nitrogen ratio

    The proportion of patients receiving a parenteral nutrition formula with a non-protein calorie-to-nitrogen ratio (C/N ratio) equal to or greater than 100 kilocalories per gram of nitrogen (≥100 kcal/g N).

    Time frame: From catheter insertion until removal or discharge, assessed up to 24 months.

  2. Incidence of lymphocytopenia

    The proportion of patients with lymphocytopenia at baseline.

    Time frame: Baseline.

  3. Proportion of patients with high parenteral nutrition energy supply

    The proportion of patients whose average proportion of daily energy from PN to measured resting energy expenditure (PN/REE) exceeds 0.6 during the catheter indwelling period.

    Time frame: From catheter insertion until removal or discharge, assessed up to 24 months.

  4. Incidence of neutropenia

    The proportion of patients with neutropenia at baseline.

    Time frame: Baseline

  5. All-cause length of hospital stay

    The total duration of hospitalization, measured in days, from admission to discharge.

    Time frame: At the time of hospital discharge, assessed up to 24 months.

  6. Total hospitalization costs

    The total direct medical costs (in CNY) incurred during the hospitalization.

    Time frame: At the time of hospital discharge, assessed up to 24 months.

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Study locations

1 site
  • Jinling Hospital
    Nanjing, Jiangsu, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2025 to primary completion in Jun 2025, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 1, 2025
First posted
Sep 15, 2025
StartActual
Jan 1, 2025
Primary completionActual
Jun 1, 2025
CompletionActual
Jun 30, 2025
Last update
Sep 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07172711
Responsible party
Wang Xinying (Professor of Medicine, Jinling Hospital, China) — Principal investigator
First posted
Sep 15, 2025
Start date
Jan 1, 2025
Primary completion
Jun 1, 2025
Completion
Jun 30, 2025
Last update
Sep 15, 2025

Study contacts

Xinying Wang
study chair · Jinling Hospital, China

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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