CRP and PCT as Predictors of Sepsis Cause

CRP and PCT as Predictors of Bloodstream Infections in Surgical Patients With Isolation of G+ and G- Bacteria in 3 Year Period

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Gram-negative Bacteremia; Gram-Positive Bacteremia
• Intervention / Treatment: Diagnostic test: PCT levels; Diagnostic test: CRP levels; Diagnostic test: White blood cell count; Diagnostic test: Platelet count

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.

• Study Type: Observational
• Enrollment (Actual): 81

Contacts and Locations

Study Locations

• Croatia
  • Osijek, Croatia, 31000
    • University Hospital Osijek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• younger of 18 years old

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gram negative; Patients who had at least one blood culture with a gram- isolate during hospitalisation in the surgical ICU	Diagnostic test: PCT levels; All patients will have their serum PCT level recorded on the day of the positive blood culture and in the next three days.; Diagnostic test: CRP levels; All patients will have their serum CRP level recorded on the day of the positive blood culture and in the next three days.; Diagnostic test: White blood cell count; All patients will have their white blood cell (WBC) count recorded on the day of the positive blood culture and in the next three days.; Diagnostic test: Platelet count; All patients will have their platelets count recorded on the day of the positive blood culture and in the next three days.
Gram positive; Patients who had at least one blood culture with a gram+ isolate during hospitalisation in the surgical ICU	Diagnostic test: PCT levels; All patients will have their serum PCT level recorded on the day of the positive blood culture and in the next three days.; Diagnostic test: CRP levels; All patients will have their serum CRP level recorded on the day of the positive blood culture and in the next three days.; Diagnostic test: White blood cell count; All patients will have their white blood cell (WBC) count recorded on the day of the positive blood culture and in the next three days.; Diagnostic test: Platelet count; All patients will have their platelets count recorded on the day of the positive blood culture and in the next three days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive level of PCT	Predictive serum level of PCT in differentiating gram+ from gram- blood culture	4 days
Predictive level of CRP	Predictive serum level of CRP in differentiating gram+ from gram- blood culture	4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
White blood cells count	Test for differences in WBC count between patients with gram+ and gram- blood cultures	4 days
Platelets count	Test for differences in platelets count between patients with gram+ and gram- blood cultures	4 days
PCT levels and outcome	To examine differences in serum PCT levels between patients who survived and those who died	4 days
CRP levels and outcome	To examine differences in serum CRP levels between patients who survived and those who died	4 days

Collaborators and Investigators

• Sponsor: Osijek University Hospital
• Investigators: Study Chair: Nenad Neskovic, PhD, Principal Investigator

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Actual): July 10, 2023
• Study Completion (Actual): July 10, 2023

Study Registration Dates

• First Submitted: October 30, 2022
• First Submitted That Met QC Criteria: October 30, 2022
• First Posted (Actual): November 4, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Bacteremia
• Other Study ID Numbers: PCT retrospective

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No