CRP and PCT as Predictors of Sepsis Cause

Sponsor
Osijek University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05605275
Collaborator
(none)
100
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
CRP and PCT as Predictors of Bloodstream Infections in Surgical Patients With Isolation of G+ and G- Bacteria in 3 Year Period
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Predictive level of PCT [4 days]

    Predictive serum level of PCT in differentiating gram+ from gram- blood culture

  2. Predictive level of CRP [4 days]

    Predictive serum level of CRP in differentiating gram+ from gram- blood culture

Secondary Outcome Measures

  1. White blood cells count [4 days]

    Test for differences in WBC count between patients with gram+ and gram- blood cultures

  2. Platelets count [4 days]

    Test for differences in platelets count between patients with gram+ and gram- blood cultures

  3. PCT levels and outcome [4 days]

    To examine differences in serum PCT levels between patients who survived and those who died

  4. CRP levels and outcome [4 days]

    To examine differences in serum CRP levels between patients who survived and those who died

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • hospitalisation in surgical ICU

  • diagnosis of sepsis

  • gram+ blood culture isolate

  • gram- blood culture isolate

Exclusion Criteria:
  • younger of 18 years old

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Osijek Osijek Croatia 31000

Sponsors and Collaborators

  • Osijek University Hospital

Investigators

  • Study Chair: Nenad Neskovic, PhD, Principal Investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Osijek University Hospital
ClinicalTrials.gov Identifier:
NCT05605275
Other Study ID Numbers:
  • PCT retrospective
First Posted:
Nov 4, 2022
Last Update Posted:
Nov 4, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 4, 2022