Catheter-related Bloodstream InfectionNCT07172711
Risk Factors for Catheter-Related Bloodstream Infections in Hospitalized Intestinal Failure Patients
An observational study of Catheter-related Bloodstream Infection and Intestinal Failure, run by Jinling Hospital, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Catheter-related Bloodstream Infection, Intestinal Failure
- How many people
- 321 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 Jun 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients meeting the ESPEN 2023 diagnostic criteria for intestinal failure.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subtype-Specific Catheter-Related Bloodstream Infection Risk Factors in Hospitalized Patients With Intestinal Failure: A Retrospective Study
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.
- Medical subject headings
- Intestinal Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CRBSIs | Patients with intestinal failure who developed catheter-related bloodstream infection | |
| Non-CRBSI | Patients with intestinal failure who never developed catheter-related bloodstream infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence rate of catheter-related bloodstream infection
frequency of catheter-related bloodstream infections occurring every 1,000 days
Measured: From catheter insertion until removal or discharge, assessed up to 24 months.
Secondary outcomes (6)
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).
Measured: From catheter insertion until removal or discharge, assessed up to 24 months.
Incidence of lymphocytopenia
The proportion of patients with lymphocytopenia at baseline.
Measured: Baseline.
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.
Measured: From catheter insertion until removal or discharge, assessed up to 24 months.
Incidence of neutropenia
The proportion of patients with neutropenia at baseline.
Measured: Baseline
All-cause length of hospital stay
The total duration of hospitalization, measured in days, from admission to discharge.
Measured: At the time of hospital discharge, assessed up to 24 months.
Total hospitalization costs
The total direct medical costs (in CNY) incurred during the hospitalization.
Measured: At the time of hospital discharge, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Jan 2025
- Primary completion1 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter-related Bloodstream InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Xinying, Jinling Hospital, China
- Investigators
- Xinying Wang, Study chair, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172711
- Sponsor's protocol ID
- 20250901
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subtype-Specific Catheter-Related Bloodstream Infection Risk Factors in Hospitalized Patients With Intestinal Failure: A Retrospective Study
- ClinicalTrials.gov ID
- NCT07172711
- Acronym / sponsor ID
- 20250901
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRBSIs | – | –Patients with intestinal failure who developed catheter-related bloodstream infection |
| Non-CRBSI | – | –Patients with intestinal failure who never developed catheter-related bloodstream infection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients meeting the ESPEN 2023 diagnostic criteria for intestinal failure.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
Proportion of patients with high calorie-to-nitrogen ratio
Time frame: From catheter insertion until removal or discharge, assessed up to 24 months.
Incidence of lymphocytopenia
Time frame: Baseline.
Proportion of patients with high parenteral nutrition energy supply
Time frame: From catheter insertion until removal or discharge, assessed up to 24 months.
Incidence of neutropenia
Time frame: Baseline
All-cause length of hospital stay
Time frame: At the time of hospital discharge, assessed up to 24 months.
Total hospitalization costs
Time frame: At the time of hospital discharge, assessed up to 24 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xinying Wang study chair
Jinling Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Catheter-related Bloodstream Infection and Intestinal Failure, run by Jinling Hospital, China 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Sep 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence rate of catheter-related bloodstream infection (time frame: From catheter insertion until removal or discharge, assessed up to 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2025.