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NCT Number: NCT05605275

CRP and PCT as Predictors of Sepsis Cause

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.

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Key information

Conditions

Sepsis Gram-Positive Bacteremia Gram-negative Bacteremia Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Osijek

Osijek, 31000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • younger of 18 years old

Treatment and study plan

PCT levels

Diagnostic Test

All patients will have their serum PCT level recorded on the day of the positive blood culture and in the next three days.

CRP levels

Diagnostic Test

All patients will have their serum CRP level recorded on the day of the positive blood culture and in the next three days.

White blood cell count

Diagnostic Test

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.

Platelet count

Diagnostic Test

All patients will have their platelets count recorded on the day of the positive blood culture and in the next three days.

Primary outcomes

  1. Predictive level of PCT

    Time frame: 4 days

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

  2. Predictive level of CRP

    Time frame: 4 days

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

Secondary outcomes

  1. White blood cells count

    Time frame: 4 days

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

  2. Platelets count

    Time frame: 4 days

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

  3. PCT levels and outcome

    Time frame: 4 days

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

  4. CRP levels and outcome

    Time frame: 4 days

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

Sponsors and collaborators

Lead sponsor

Osijek University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 4, 2022
Registry last updated
Jul 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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