CRP and PCT as Predictors of Sepsis Cause

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05605275
• Other study ID #: PCT retrospective
• Status: Completed
• Start date: January 5, 2022
• Est. completion date: July 10, 2023

Study information

• Verified date: October 2022
• Source: Osijek University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: July 10, 2023
• Est. primary completion date: July 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• hospitalisation in surgical ICU

• diagnosis of sepsis

• gram+ blood culture isolate

• gram- blood culture isolate

Exclusion Criteria:

• younger of 18 years old

Related Conditions & MeSH terms

• Bacteremia
• Gram-negative Bacteremia
• Sepsis

Intervention

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

Locations

Country	Name	City	State
Croatia	University Hospital Osijek	Osijek

Sponsors (1)

Lead Sponsor	Collaborator
Osijek University Hospital

Country where clinical trial is conducted

Croatia, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive level of PCT	Predictive serum level of PCT in differentiating gram+ from gram- blood culture	4 days
Primary	Predictive level of CRP	Predictive serum level of CRP in differentiating gram+ from gram- blood culture	4 days
Secondary	White blood cells count	Test for differences in WBC count between patients with gram+ and gram- blood cultures	4 days
Secondary	Platelets count	Test for differences in platelets count between patients with gram+ and gram- blood cultures	4 days
Secondary	PCT levels and outcome	To examine differences in serum PCT levels between patients who survived and those who died	4 days
Secondary	CRP levels and outcome	To examine differences in serum CRP levels between patients who survived and those who died	4 days