NCT06991686

Comparison Between the Progostic Value of the Procalcitonin and the Platelet/Total Leukocytic Count Ratio in Sepsis

Completed Last updated 18 June 2025

What this trial tests

trial testing Blood samples in All Conditions Causing Sepsis in 100 participants. Completed in 10 March 2025.

Timeline

27 September 2024

Primary endpoint
15 February 2025

10 March 2025

Quick facts

Lead sponsor	Ain Shams University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	100
Start date	27 September 2024
Primary completion	15 February 2025
Estimated completion	10 March 2025
Sites	1 location across Egypt

Drugs / interventions tested

• Blood samples — full drug profile →
• blood sample — full drug profile →

Conditions studied

• All Conditions Causing Sepsis — all drugs for All Conditions Causing Sepsis →
• Pneumonia - Bacterial — all drugs for Pneumonia - Bacterial →
• Urinary Tract Infection Bacterial — all drugs for Urinary Tract Infection Bacterial →

Sponsor

Ain Shams University

Who can join

21 and older, any sex, with All Conditions Causing Sepsis or Pneumonia - Bacterial. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

What is already known on this subject? AND What does this study add? Sepsis is a complicated condition caused by a malfunction of the host's immune response to infection, which results in an uncontrollable inflammatory response and immunosuppression.

Sepsis is seen as a global health problem with significant economic effects .As a result, identifying prognostic and diagnostic biomarkers is critical in order to avoid adverse outcomes and reduce mortality by initiating treatment before irreversible damage occurs. A delay of one hour in sepsis treatment is thought to be associated with a 7-10 percent increase in sepsis-related death . As a result, many efforts have been made to find a viable biomarker for screening sepsis patients who are at a high risk of death.

Procalciotnin and platelet/leukocytic count ratio have been studied before but there are few studies comparing them.

Multiple studies have elucidated the benefits associated with the precursor molecule of calcitonin, specifically PCT, as a biomarker for sepsis.

In recent years, there has been a growing body of research indicating that platelets (PLT) and total leukocytic count are significant contributors to the inflammatory process. Previous research suggests a possible association between platelet/total leukocytic count ratio and sepsis mortality.

In this study will compare between the prognostic value of procalcitonin and the platelet/total leukocytic count ratio in sepsis.

AIM/ OBJECTIVES The aim of this prospective cross-sectional study was to compare the PCT level and the platelet/total leukocytic count ratio for survival prediction in patients with Sepsis.

METHODOLOGY:

* Type of Study: Prospective cross-sectional Study
* Study Setting: This study was conducted at Ain Shams University intensive care units.
* Study Period: Six months after approval of ethical committee of Faculty of Medicine, Ain Shams University or end of recruited sample size.

Sample Size:

Assuming an AUC for procalcitonin of 0.977 and that of platelet/total leukocytic count ratio of 0.944, a sample of 100 patients would be enough to detect such difference with 0.11 allowable difference between the 2 AUC, at 0.05 alpha error and 0.80 power of the test .

Ethical considerations

* The approval of the Scientific Research Ethics Committee at the Faculty of Medicine, Ain Shams University was obtained before starting work on the study.
* All data were considered confidential and weren't used outside this study without patient approval.
* Informed written consent was taken from all patients after explaining the study procedure in details.

Data collected and period of the study:

Clinical data and laboratory indicators, including gender, age, vital signs, past medical history such as hypertension and diabetes, SOFA score, APACHE II score, PLT, and PCT, were recorded within 24 hours of admission. Sepsis patients were observed and followed up for 28 days. Patient survival and death was recorded.

CBC was done every other day and serum procalcitonin was done every 72 hours for 28 days and the results were analysed and compared in correlation with patient's survivability.

Data management and analysis All data will be analyzed statistically. All data will be included in the SPSS software version 21. The appropriate statistical method will be used for analysis. Descriptive statistics such as mean, standard deviation and percentages will be used. Comparison of categorical data will be done using Chi-square test and for continuous data; unpaired "t" test will be used.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.