SepsisNCT06958354
Evaluation of the Clinical Relationship Between Procalcitonin Level and Bacteremia Agent in Intensive Care Unit Patients
An observational study of Sepsis and Septic, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In intensive care units, sepsis, which can be defined as bacteremia and the irregular and uncontrolled inflammatory response to it, is one of the most important causes of mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic, Bacteremia and Sepsis
- How many people
- 1,529 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2023to 19 Oct 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Among the patients who were followed up in the intensive care unit between 01.01.2018 and 01.01.2023 and who were found to have a positive blood culture during their follow up, only those whose PCT results were obtained within 24 hours, based on the time the blood culture sample was taken, will be included.
Who may be able to join
- Positive blood culture during their follow up
- Patients over 18 years of age
Who cannot join
- Those under the age of 18
- Those who have had surgery or trauma in the last 72 hours
- Those with a history of autoimmune disease, chronic renal failure
- Patients admitted to intensive care due to acute pancreatitis, pregnancy, burns.
- Patients with incomplete data.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Training and Research Hospital
Ankara, Türkiye, 06010
About this study
In intensive care units, sepsis, which can be defined as bacteremia and the irregular and uncontrolled inflammatory response to it, is one of the most important causes of mortality. Early recognition of sepsis and appropriate antibiotic use for the causative agent is one of the most important steps in the fight against sepsis. Procalcitonin (PCT) is a calcitonin precursor peptide and has been reported to predict bacteremia early. While the PCT concentration level is negligible in healthy individuals, it has been shown to increase especially in bacterial infections, sepsis, trauma and burns. In our study, our aim is to determine whether there is a relationship between serum PCT concentration levels taken within 24 hours according to the time of the sample taken for blood culture with growth in patients followed up in our Internal Intensive Care Unit.
- Conditions
- Sepsis, Septic, Bacteremia and Sepsis, Intensive Care Medicine, Procalcitonin
- Keywords
- procalcitonin, sepsis, septic shock, intrensive care medicine
- Medical subject headings
- Sepsis, Bacteremia, Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of serum PCT levels measured within 24 hours of culture in intensive care patients with bacteremia and the pathogen type (Gram-positive, Gram-negative, fungal) in the culture result.
Measured: In patients with positive blood cultures, serum PCT values studied within the first 24 hours from the time the culture sample was taken will be evaluated retrospectively.
Secondary outcomes (1)
Diagnostic power of PCT levels in distinguishing Gram-negative, Gram-positive and fungal infections
Measured: serum PCT values studied within the first 24 hours from the time the culture sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start15 Mar 2023
- Primary completion1 Jan 2025
- Study completion19 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 1,529 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mete Erdemir, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958354
- Sponsor's protocol ID
- 2023/34
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes: Data to be Shared: Anonymized individual patient data (demographic information, laboratory results, culture results, clinical scores and mortality status). Sharing Time: After the study is completed and the results are published Sharing Conditions: Requests with ethics committee approval and scientific purposes will be evaluated with a written application. Data sharing will be done via e-mail or secure systems by signing a data usage protocol. Sharing Scope: Only anonymous data will be shared, excluding identifying personal information
Publications
Muller F, Christ-Crain M, Bregenzer T, Krause M, Zimmerli W, Mueller B, Schuetz P; ProHOSP Study Group. Procalcitonin levels predict bacteremia in patients with community-acquired pneumonia: a prospective cohort trial. Chest. 2010 Jul;138(1):121-9. doi: 10.1378/chest.09-2920. Epub 2010 Mar 18.
PubMed 20299634Liu D, Su L, Han G, Yan P, Xie L. Prognostic Value of Procalcitonin in Adult Patients with Sepsis: A Systematic Review and Meta-Analysis. PLoS One. 2015 Jun 15;10(6):e0129450. doi: 10.1371/journal.pone.0129450. eCollection 2015.
PubMed 26076027Leli C, Ferranti M, Moretti A, Al Dhahab ZS, Cenci E, Mencacci A. Procalcitonin levels in gram-positive, gram-negative, and fungal bloodstream infections. Dis Markers. 2015;2015:701480. doi: 10.1155/2015/701480. Epub 2015 Mar 17.
PubMed 25852221https://pmc.ncbi.nlm.nih.gov/articles/PMC6289022/
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Relationship Between Procalcitonin Level and Bacteremia Agent in Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT06958354
- Acronym / sponsor ID
- 2023/34
- Conditions
- Sepsis, Septic, Bacteremia and Sepsis, Intensive Care Medicine, Procalcitonin
- Keywords
- procalcitonin, sepsis, septic shock, intrensive care medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,529 participants (actual)
- Lead sponsor
- Gulhane Training and Research HospitalOther government
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 19 Oct 2025 (actual)
- First posted
- 6 May 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.
In intensive care units, sepsis, which can be defined as bacteremia and the irregular and uncontrolled inflammatory response to it, is one of the most important causes of mortality. Early recognition of sepsis and appropriate antibiotic use for the causative agent is one of the most important steps in the fight against sepsis. Procalcitonin (PCT) is a calcitonin precursor peptide and has been reported to predict bacteremia early. While the PCT concentration level is negligible in healthy individuals, it has been shown to increase especially in bacterial infections, sepsis, trauma and burns. In our study, our aim is to determine whether there is a relationship between serum PCT concentration levels taken within 24 hours according to the time of the sample taken for blood culture with growth in patients followed up in our Internal Intensive Care Unit.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Among the patients who were followed up in the intensive care unit between 01.01.2018 and 01.01.2023 and who were found to have a positive blood culture during their follow up, only those whose PCT results were obtained within 24 hours, based on the time the blood culture sample was taken, will be included.
Key inclusion criteria (2 listed)
- Positive blood culture during their follow up
- Patients over 18 years of age
Key exclusion criteria (5 listed)
- Those under the age of 18
- Those who have had surgery or trauma in the last 72 hours
- Those with a history of autoimmune disease, chronic renal failure
- Patients admitted to intensive care due to acute pancreatitis, pregnancy, burns.
- Patients with incomplete data.
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
Correlation of serum PCT levels measured within 24 hours of culture in intensive care patients with bacteremia and the pathogen type (Gram-positive, Gram-negative, fungal) in the culture result.
Time frame: In patients with positive blood cultures, serum PCT values studied within the first 24 hours from the time the culture sample was taken will be evaluated retrospectively.
1 secondary outcome
Diagnostic power of PCT levels in distinguishing Gram-negative, Gram-positive and fungal infections
Time frame: serum PCT values studied within the first 24 hours from the time the culture sample
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 11 Dec 2025.
- Background: PubMed 20299634Muller F, Christ-Crain M, Bregenzer T, Krause M, Zimmerli W, Mueller B, Schuetz P; ProHOSP Study Group. Procalcitonin levels predict bacteremia in patients with community-acquired pneumonia: a prospective cohort trial. Chest. 2010 Jul;138(1):121-9. doi: 10.1378/chest.09-2920. Epub 2010 Mar 18.
- Background: PubMed 26076027Liu D, Su L, Han G, Yan P, Xie L. Prognostic Value of Procalcitonin in Adult Patients with Sepsis: A Systematic Review and Meta-Analysis. PLoS One. 2015 Jun 15;10(6):e0129450. doi: 10.1371/journal.pone.0129450. eCollection 2015.
- Background: PubMed 25852221Leli C, Ferranti M, Moretti A, Al Dhahab ZS, Cenci E, Mencacci A. Procalcitonin levels in gram-positive, gram-negative, and fungal bloodstream infections. Dis Markers. 2015;2015:701480. doi: 10.1155/2015/701480. Epub 2015 Mar 17.
- Backgroundhttps://pmc.ncbi.nlm.nih.gov/articles/PMC6289022/
- Individual participant dataSharing planned: Yes. Data to be Shared: Anonymized individual patient data (demographic information, laboratory results, culture results, clinical scores and mortality status). Sharing Time: After the study is completed and the results are published Sharing Conditions: Requests with ethics committee approval and scientific purposes will be evaluated with a written application. Data sharing will be done via e-mail or secure systems by signing a data usage protocol. Sharing Scope: Only anonymous data will be shared, excluding identifying personal information
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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 Sepsis and Septic, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 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 11 Dec 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 Turkey (Türkiye). 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?
Correlation of serum PCT levels measured within 24 hours of culture in intensive care patients with bacteremia and the pathogen type (Gram-positive, Gram-negative, fungal) in the culture result. (time frame: In patients with positive blood cultures, serum PCT values studied within the first 24 hours from the time the culture sample was taken will be evaluated retrospectively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06958354, which also lists 4 linked publications.
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 11 Dec 2025.