NCT05605275

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 4, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2023

Completed
Last Updated

July 18, 2023

Status Verified

October 1, 2022

Enrollment Period

1.5 years

First QC Date

October 30, 2022

Last Update Submit

July 14, 2023

Conditions

SepsisGram-Positive BacteremiaGram-negative Bacteremia

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • White blood cells count

    4 days

  • Platelets count

    4 days

  • PCT levels and outcome

    4 days

  • CRP levels and outcome

    4 days

Study Arms (2)

Gram negative

Patients who had at least one blood culture with a gram- isolate during hospitalisation in the surgical ICU

Diagnostic Test: PCT levelsDiagnostic Test: CRP levelsDiagnostic Test: White blood cell countDiagnostic Test: Platelet count

Gram positive

Patients who had at least one blood culture with a gram+ isolate during hospitalisation in the surgical ICU

Diagnostic Test: PCT levelsDiagnostic Test: CRP levelsDiagnostic Test: White blood cell countDiagnostic Test: Platelet count

Interventions

PCT levelsDIAGNOSTIC_TEST

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

Gram negativeGram positive
CRP levelsDIAGNOSTIC_TEST

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

Gram negativeGram positive
White blood cell countDIAGNOSTIC_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.

Gram negativeGram positive
Platelet countDIAGNOSTIC_TEST

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

Gram negativeGram positive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • younger of 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Osijek

Osijek, 31000, Croatia

Location

Related Publications (6)

  • 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.

    PMID: 12071576BACKGROUND

  • 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.

    PMID: 8094770BACKGROUND

  • 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.

    PMID: 21808399BACKGROUND

  • 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.

    PMID: 25726038BACKGROUND

  • 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.

    PMID: 30497960BACKGROUND

  • 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.

    PMID: 34675564BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

The values of PCT, CRP, white blood cells and platelets will be recorded retrospectively for all patients included in the study

MeSH Terms

Conditions

Sepsis

Interventions

Leukocyte CountPlatelet Count

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Cell CountCell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaPlatelet Function Tests

Study Officials

  • Nenad Neskovic, PhD

    Principal Investigator

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2022

First Posted

November 4, 2022

Study Start

January 5, 2022

Primary Completion

July 10, 2023

Study Completion

July 10, 2023

Last Updated

July 18, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

CR(1)