CLABSI - Central Line Associated Bloodstream InfectionNCT07674992
Risk Factors for PICC-Related Infection in 994 High-Risk Patients: The Role of Hb Levels and Sampling Frequency
An observational study of CLABSI - Central Line Associated Bloodstream Infection, run by Mahidol University at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CLABSI - Central Line Associated Bloodstream Infection
- What is being tested?
- Hemoglobin level
- How many people
- 1,239 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2023to 1 Apr 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critcally illed patient or patient with cancer who was inserted PICC line
Who may be able to join
- Patient with PICC line more than 48 hours, performed by Anesthesia Department from January 2023 to December 2024
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Hemoglobin level
- Keywords
- Catheters, Peripherally Inserted Central; Catheter-Related Infections, CLABSI, Hemoglobin threshold, Risk factors
- Medical subject headings
- Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemoglobin levelOther
Hb ≤ 9.6 g/dL
| Study group | Role | What they receive |
|---|---|---|
| non CLABSI | non CLABSI | |
| CLABSI | Patient with CLABSI Receives: Other: Hemoglobin level |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of CLABSI
incidence of CLABSI
Measured: From January 2023 to December 2024
Secondary outcomes (1)
Study the risk factors related to CLABSI, including clinical factors, comorbidities, indication for PICC, and laboratory.
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.
Measured: From January 2023 to December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Jan 2023
- Primary completion31 Dec 2025
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLABSI - Central Line Associated Bloodstream InfectionStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sawita Kanavitoon, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674992
- Sponsor's protocol ID
- Si327/2025
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 30 Jun 2026
- 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 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for PICC-Related Infection in 994 High-Risk Patients: The Role of Hb Levels and Sampling Frequency-A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07674992
- Acronym / sponsor ID
- Si327/2025
- Keywords
- Catheters, Peripherally Inserted Central; Catheter-Related Infections, CLABSI, Hemoglobin threshold, Risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,239 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 30 Jun 2026 (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 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non CLABSI | – | –non CLABSI |
| CLABSI | – | Other: Hemoglobin levelPatient with CLABSI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critcally illed patient or patient with cancer who was inserted PICC line
Key inclusion criteria (1 listed)
- Patient with PICC line more than 48 hours, performed by Anesthesia Department from January 2023 to December 2024
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemoglobin levelHb ≤ 9.6 g/dL | Other | CLABSI |
Primary outcome
rate of CLABSI
Time frame: From January 2023 to December 2024
incidence of CLABSI
1 secondary outcome
Study the risk factors related to CLABSI, including clinical factors, comorbidities, indication for PICC, and laboratory.
Time frame: From January 2023 to December 2024
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 30 Jun 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 CLABSI - Central Line Associated Bloodstream Infection, run by Mahidol University at 1 site in Thailand.
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 5 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 30 Jun 2026. 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 Thailand. 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?
rate of CLABSI (time frame: From January 2023 to December 2024). 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 30 Jun 2026.