NCT06958354

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,529

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 6, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2025

Completed
Last Updated

December 11, 2025

Status Verified

April 1, 2025

Enrollment Period

1.8 years

First QC Date

April 24, 2025

Last Update Submit

December 4, 2025

Conditions

Keywords

procalcitoninsepsisseptic shockintrensive care medicine

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    serum PCT values studied within the first 24 hours from the time the culture sample

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Positive blood culture during their follow up
  • Patients over 18 years of age

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane Training and Research Hospital

Ankara, Türkiye, 06010, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 20299634BACKGROUND
  • Liu 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.

    PMID: 26076027BACKGROUND
  • Leli 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.

    PMID: 25852221BACKGROUND
  • https://pmc.ncbi.nlm.nih.gov/articles/PMC6289022/

    BACKGROUND

MeSH Terms

Conditions

SepsisBacteremiaShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsBacterial InfectionsBacterial Infections and MycosesShock

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist

Study Record Dates

First Submitted

April 24, 2025

First Posted

May 6, 2025

Study Start

March 15, 2023

Primary Completion

January 1, 2025

Study Completion

October 19, 2025

Last Updated

December 11, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR

Locations