Clinical trial NCT06958354: Evaluation of the Clinical Relationship Between Procalcitonin Level and Bacteremia Agent in Intensive Care Unit Patients
Official title: Evaluation of the Clinical Relationship Between Procalcitonin Level and Bacteremia Agent in Intensive Care Unit Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Sepsis
Septic
Bacteremia and Sepsis
Intensive Care Medicine
Procalcitonin
Keywords: procalcitonin
sepsis
septic shock
intrensive care medicine
Lead sponsor: Gulhane Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-05-06
Enrollment: 1529
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
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.
timeFrame: 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:
measure: Diagnostic power of PCT levels in distinguishing Gram-negative, Gram-positive and fungal infections
timeFrame: serum PCT values studied within the first 24 hours from the time the culture sample
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane Training and Research Hospital
state: Türkiye
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: https://pmc.ncbi.nlm.nih.gov/articles/PMC6289022/