- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07674992
Risk Factors for PICC-Related Infection in 994 High-Risk Patients: The Role of Hb Levels and Sampling Frequency
June 23, 2026 updated by: Sawita Kanavitoon, Mahidol University
Risk Factors for PICC-Related Infection in 994 High-Risk Patients: The Role of Hb Levels and Sampling Frequency-A Retrospective Cohort Study
This retrospective cohort study aims to evaluate the incidence and clinical predictors of Central Line-Associated Bloodstream Infections (CLABSI) in patients receiving Peripherally Inserted Central Catheters (PICCs) via the Anesthesia Department.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1239
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bangkok
-
Bangkok Noi, Bangkok, Thailand, 10700
- Siriraj Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Critcally illed patient or patient with cancer who was inserted PICC line
Description
Inclusion Criteria:
- Patient with PICC line more than 48 hours, performed by Anesthesia Department from January 2023 to December 2024
Exclusion Criteria:
- Incomplete data
- Patient with reported colonization of PICC line
- Patient with unintended position of PICC line
- Patient with any other central venous catheter besides PICC line
- Patient with previously reported as CLABSI
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
non CLABSI
|
|
|
CLABSI
Patient with CLABSI
|
Hb ≤ 9.6 g/dL
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
rate of CLABSI
Time Frame: From January 2023 to December 2024
|
incidence of CLABSI
|
From January 2023 to December 2024
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Study the risk factors related to CLABSI, including clinical factors, comorbidities, indication for PICC, and laboratory.
Time Frame: From January 2023 to December 2024
|
To evaluate potential risk factors for CLABSI, baseline demographic, clinical, and procedural characteristics will be collected at PICC line insertion and analyzed using two aggregated formats: continuous variables will be reported as means (with SD) or medians (with IQR): age (years), weight (kg), height (m), combined BMI (kg/m^2), procedure duration (minutes), catheter indwelling time (days), hemoglobin (g/dL), and white blood cell counts (cells/µL).
Categorical variables will be reported as percentages/proportions: sex, ICU admission, preprocedural antibiotics, procedure duration <60 minutes, indwelling time ≤6 weeks, comorbidities (immunocompromised, hypertension, liver disease, diabetes, oncologic/hematologic malignancies), and insertion indications (TPN, CMT, prolonged IV meds, frequent blood sampling, vasopressors).
All variables will be analyzed via regression to identify independent predictors of CLABSI.
|
From January 2023 to December 2024
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Actual)
December 31, 2025
Study Completion (Actual)
April 1, 2026
Study Registration Dates
First Submitted
June 2, 2026
First Submitted That Met QC Criteria
June 23, 2026
First Posted (Actual)
June 30, 2026
Study Record Updates
Last Update Posted (Actual)
June 30, 2026
Last Update Submitted That Met QC Criteria
June 23, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Si327/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.