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Completed

NCT Number: NCT07172711

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

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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Key information

Conditions

Catheter-related Bloodstream Infection Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Intestinal Failure

Sex eligibility

All sexes

Study type

Observational

Primary location

Jinling Hospital

Nanjing, Jiangsu, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

Primary outcomes

  1. incidence rate of catheter-related bloodstream infection

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

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

Secondary outcomes

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

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

    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).

  2. Incidence of lymphocytopenia

    Time frame: Baseline.

    The proportion of patients with lymphocytopenia at baseline.

  3. Proportion of patients with high parenteral nutrition energy supply

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

    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.

  4. Incidence of neutropenia

    Time frame: Baseline

    The proportion of patients with neutropenia at baseline.

  5. All-cause length of hospital stay

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

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

  6. Total hospitalization costs

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

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

Sponsors and collaborators

Lead sponsor

Jinling Hospital, China

Other

Registry information

Official study title

Subtype-Specific Catheter-Related Bloodstream Infection Risk Factors in Hospitalized Patients With Intestinal Failure: A Retrospective Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 15, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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