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

NCT06991686 | Completed

• 1 other identifier: FMASU MS 598/2024
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

All Conditions Causing Sepsis; Pneumonia - Bacterial; Urinary Tract Infection Bacterial

Keywords

sepsis; procalcitonin; prognosis; platelet/total leukocytic count ratio; outcome; prognostic value; septic patients

Outcome Measures

Primary Outcomes (1)

• mortality

  survival or death of the patient

  28 days

Interventions

Blood samples DIAGNOSTIC_TEST

blood sample for CBC and procalcitonin

blood sample DIAGNOSTIC_TEST

blood sample for procalcitonin and CBC

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study was carried out on adult critically ill patients of both sexes with sepsis whom admitted to the Critical Care units of Ain Shams University Hospitals.

You may qualify if:

• Age more than 21 years.
• Patients presented with sepsis defined as a suspected source of infection plus ≥2 of the following:
• Fever of \>38º or hypothermia \<36º
• Heart rate of \>90 beats/min
• Respiratory rate of \>20 breaths per minute or PaCO2 \<32 mmHg
• White blood cells \>12 x 109/cmm or \<4 x 109/cmm, or \>10% immature forms.
• Patients presented with severe sepsis defined as sepsis associated with secondary organ dysfunction.

You may not qualify if:

• Age less than 21 years.
• Patients with acute cerebro-vascular event.
• Patients on chemotherapy.
• Patients with malignant hematological disease.
• Patients with immunosuppression.
• Patients with active hemorrhage.
• Patients who had used anti-PLT drugs such as clopidogrel prior to admission.
• Patients with life threating medical comorbidities (e.g.intractable heart failure, hepatic encephalopathy).
• Patients diagnosed with heparin induced thrombocytopenia (HIT).
• Patients on medications that help reducing platelet count such as linezolid.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Meidcine Ain Shams University

Cairo, Egypt

Location

Related Publications (10)

• Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.

  PMID: 34599691 BACKGROUND

• Shannon O. The role of platelets in sepsis. Res Pract Thromb Haemost. 2020 Dec 20;5(1):27-37. doi: 10.1002/rth2.12465. eCollection 2021 Jan.

  PMID: 33537527 BACKGROUND

• Standage SW, Wong HR. Biomarkers for pediatric sepsis and septic shock. Expert Rev Anti Infect Ther. 2011 Jan;9(1):71-9. doi: 10.1586/eri.10.154.

  PMID: 21171879 BACKGROUND

• Kim H, Kim Y, Lee HK, Kim KH, Yeo CD. Comparison of the delta neutrophil index with procalcitonin and C-reactive protein in sepsis. Clin Lab. 2014;60(12):2015-21. doi: 10.7754/clin.lab.2014.140528.

  PMID: 25651736 BACKGROUND

• de Souza DC, Machado FR. Epidemiology of Pediatric Septic Shock. J Pediatr Intensive Care. 2019 Mar;8(1):3-10. doi: 10.1055/s-0038-1676634. Epub 2018 Dec 28.

  PMID: 31073502 BACKGROUND

• Huang M, Cai S, Su J. The Pathogenesis of Sepsis and Potential Therapeutic Targets. Int J Mol Sci. 2019 Oct 29;20(21):5376. doi: 10.3390/ijms20215376.

  PMID: 31671729 BACKGROUND

• Paoli CJ, Reynolds MA, Sinha M, Gitlin M, Crouser E. Epidemiology and Costs of Sepsis in the United States-An Analysis Based on Timing of Diagnosis and Severity Level. Crit Care Med. 2018 Dec;46(12):1889-1897. doi: 10.1097/CCM.0000000000003342.

  PMID: 30048332 BACKGROUND

• Andersson P, Frigyesi A. High-sensitivity troponin T is an important independent predictor in addition to the Simplified Acute Physiology Score for short-term ICU mortality, particularly in patients with sepsis. J Crit Care. 2019 Oct;53:218-222. doi: 10.1016/j.jcrc.2019.06.018. Epub 2019 Jun 19.

  PMID: 31277048 BACKGROUND

• Rello J, Valenzuela-Sanchez F, Ruiz-Rodriguez M, Moyano S. Sepsis: A Review of Advances in Management. Adv Ther. 2017 Nov;34(11):2393-2411. doi: 10.1007/s12325-017-0622-8. Epub 2017 Oct 11.

  PMID: 29022217 BACKGROUND

• Agnello L, Giglio RV, Bivona G, Scazzone C, Gambino CM, Iacona A, Ciaccio AM, Lo Sasso B, Ciaccio M. The Value of a Complete Blood Count (CBC) for Sepsis Diagnosis and Prognosis. Diagnostics (Basel). 2021 Oct 12;11(10):1881. doi: 10.3390/diagnostics11101881.

  PMID: 34679578 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Bacterial; Sepsis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 28, 2025
• Study Start: September 27, 2024
• Primary Completion: February 15, 2025
• Study Completion: March 10, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-05

Locations

EG (1)