Clinical trial NCT05605275: CRP and PCT as Predictors of Sepsis Cause
Official title: CRP and PCT as Predictors of Bloodstream Infections in Surgical Patients With Isolation of G+ and G- Bacteria in 3 Year Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Gram-Positive Bacteremia
Gram-negative Bacteremia
Lead sponsor: Osijek University Hospital
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 18 years who were hospitalized in the surgical ICU between January 2019 and May 2022 and who had at least one positive blood culture during treatment will be included in the research.

Brief summary: The aim of this retrospective study is to determine the predictive role of serum level of procalcitonin (PCT) and c-reactive protein (CRP) in determining the causative agent of sepsis in surgical intensive care unit (ICU) patients. The main question it aims to answer is: what serum level of PCT and CRP is predictive of gram+ and gram- sepsis in patients with positive blood cultures in the surgical ICU. The study will be retrospective and will include all patients with positive blood cultures who were hospitalized in the surgical ICU of University Hospital Osijek in the period from January 2019 to May 2022.

Detailed description: PCT is a good biochemical marker of severe bacterial infection. Numerous studies have confirmed its role in the diagnosis of sepsis, especially sepsis with positive blood cultures. This retrospective study will include septic patients who were hospitalised in the surgical ICU between January 2019 and May 2022, and who had at least one positive blood culture. The values of PCT, CRP, white blood cells count and platelets count, as well as the overall outcome of the treatment, will be recorded for the patients included in the research. The aim of the research is to examine the differences in the level of PCT, CRP, white blood cells count and platelets count between patients with gram+ and gram- blood cultures. Also, the predictive value of PCT and CRP in differentiating gram+ from gram- hem will be examined.

Eligibility criteria: Inclusion Criteria:

* hospitalisation in surgical ICU
* diagnosis of sepsis
* gram+ blood culture isolate
* gram- blood culture isolate

Exclusion Criteria:

* younger of 18 years old

Primary outcomes:
measure: Predictive level of PCT
timeFrame: 4 days
measure: Predictive level of CRP
timeFrame: 4 days
Secondary outcomes:
measure: White blood cells count
timeFrame: 4 days
measure: Platelets count
timeFrame: 4 days
measure: PCT levels and outcome
timeFrame: 4 days
measure: CRP levels and outcome
timeFrame: 4 days
Other outcomes:
Locations:
city: Osijek
country: Croatia
facility: University Hospital Osijek
Study officials:
affiliation: Principal Investigator
name: Nenad Neskovic, PhD
role: STUDY_CHAIR
References:
citation: Morgenthaler NG, Struck J, Fischer-Schulz C, Seidel-Mueller E, Beier W, Bergmann A. Detection of procalcitonin (PCT) in healthy controls and patients with local infection by a sensitive ILMA. Clin Lab. 2002;48(5-6):263-70.
citation: Assicot M, Gendrel D, Carsin H, Raymond J, Guilbaud J, Bohuon C. High serum procalcitonin concentrations in patients with sepsis and infection. Lancet. 1993 Feb 27;341(8844):515-8. doi: 10.1016/0140-6736(93)90277-n.
citation: Sinha M, Desai S, Mantri S, Kulkarni A. Procalcitonin as an adjunctive biomarker in sepsis. Indian J Anaesth. 2011 May;55(3):266-70. doi: 10.4103/0019-5049.82676.
citation: Hoeboer SH, van der Geest PJ, Nieboer D, Groeneveld AB. The diagnostic accuracy of procalcitonin for bacteraemia: a systematic review and meta-analysis. Clin Microbiol Infect. 2015 May;21(5):474-81. doi: 10.1016/j.cmi.2014.12.026. Epub 2015 Jan 14.
citation: Gupta S, Jaswani P, Sharma RK, Agrawal S, Prasad N, Sahu C, Gupta A, Prasad KN. Procalcitonin as a diagnostic biomarker of sepsis: A tertiary care centre experience. J Infect Public Health. 2019 May-Jun;12(3):323-329. doi: 10.1016/j.jiph.2018.11.004. Epub 2018 Nov 26.
citation: Yang L, Lin Y, Wang J, Song J, Wei B, Zhang X, Yang J, Liu B. Comparison of Clinical Characteristics and Outcomes Between Positive and Negative Blood Culture Septic Patients: A Retrospective Cohort Study. Infect Drug Resist. 2021 Oct 12;14:4191-4205. doi: 10.2147/IDR.S334161. eCollection 2021.