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

NCT07172711 | Completed

• 1 other identifier: 20250901
• Study Type: observational
• Target: 321
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Catheter-related Bloodstream Infection; Intestinal Failure

Outcome Measures

Primary Outcomes (1)

• incidence rate of catheter-related bloodstream infection

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

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

Secondary Outcomes (6)

• Proportion of patients with high calorie-to-nitrogen ratio

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

• Incidence of lymphocytopenia

  Baseline.

• Proportion of patients with high parenteral nutrition energy supply

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

• Incidence of neutropenia

  Baseline

• All-cause length of hospital stay

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

Study Arms (2)

CRBSIs

Patients with intestinal failure who developed catheter-related bloodstream infection

Non-CRBSI

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Jinling Hospital

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Intestinal Failure

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Xinying Wang

  Jinling Hospital, China

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 15, 2025
• Study Start: January 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 30, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)