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All Conditions Causing SepsisNCT06991686

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

An observational study of All Conditions Causing Sepsis and Pneumonia - Bacterial, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
Blood samples and blood sample
How many people
100 participants
Where
1 siteEgypt
Study dates
27 Sep 2024to 10 Mar 2025
How long will I take part?
28 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Meidcine Ain Shams University

    Cairo

Other trials in Egypt

About this study

Official title: Prognostic Value of Procalcitonin Vs Platelet/Total Leukocytic Count Ratio in 28 Days Outcome in Severe Septic Patients

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.

Read more

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.

Read the detailed 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.

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

  1. INTRODUCTION/ REVIEW Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection, characterized by hypotension, elevated lactate, or oliguria. It is a common disease in critically ill patients and a major cause of death in intensive care units (ICUs). Despite improved understanding and management of sepsis over the past few decades, the mortality rate remains high, ranging from 20% to 45%, and it is a prominent challenge facing modern medicine and a significant global disease burden. Sepsis presents with a diverse range of clinical manifestations, and there is a lack of specific indicators for diagnosis and prognosis evaluation, and the disease progresses rapidly. As the condition worsens, there can be dysfunction of cellular metabolic processes, resulting in sepsis, multiple organ dysfunction syndrome, poor patient outcomes, and even death. Therefore, finding laboratory indicators that can quickly assist in diagnosing sepsis is one of the urgent problems to be solved in critical care medicine. A number of physicians have conducted research on the importance of blood biomarkers, including C-reactive protein, procalcitonin (PCT), and lactate, in the early evaluation of sepsis and in predicting patient outcomes. 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. Among all the sepsis biomarkers studied, complete blood count (CBC) metrics, including the platelet to total leukocytic count ratio , could be valuable tools . Undoubtedly, CBC has many advantages: (i) it is inexpensive, (ii) it has a quick turn-around time (TAT), (iii) it is accessible in all health centers, (iv) it is simple to perform, (v) clinicians regularly request CBC as part of patient management, and (vi) it is the most commonly ordered laboratory test in all medical settings, from the ICU to the emergency department (ED) Under inflammatory conditions, platelets (PLTs) have a role in promoting coagulation factor activation and cell aggregation, which can lead to host response dysregulation. When sepsis occurs, the inflammatory response of bacteria and platelets, endotoxin-mediated platelet activation, and the effects of circulating immune complexes can all lead to platelet reduction.Platelet reduction is one of the most common complications in sepsis patients, and it is negatively correlated with the severity of sepsis and mortality rates. Procalcitonin (PCT) is a nonhormonal glycoprotein whose levels are positively correlated with the severity of bacterial infections. It has important clinical significance in predicting the prognosis of infectious diseases and is a marker of disease course and treatment success. A multicenter randomized controlled trial involving sepsis patients showed that using PCT to guide patient antibiotic use can significantly reduce infection-related adverse events, 28-day mortality, and hospitalization costs.
  2. 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.
  3. METHODOLOGY: Patients and Methods/ Subjects and Methods/ Material and Methods
  • 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. Study Tools and procedure: All patients included in this study were subjected on admission to the followings:
  1. History:
  • Personal data: name, age and gender.
  • Present history of medical condition.
  • Past medical history including:
  • Heart disease.
  • Liver disease
  • Renal disease
  • Hypertension.
  • Diabetes mellitus.
  • Hematological disorder.
  • Oncological disorder.
  1. Clinical examination:
  • Complete physical examination was done with emphasis on:
  • Vital signs: (heart rate, mean pressure, respiratory rate, temperature)
  • Mental status according to Glasgow Coma Score (GCS)
  • Chest examination.
  • Cardiac examination.
  • Abdominal examination.
  1. Clinical risk stratification:
  • APACHE II score SOFA score
  1. Laboratory investigations: Were done on admission and daily during the period of the study and included:
  • Serum Na, K.
  • Urea, creatinine.
  • Random blood sugar.
  • C-reactive protein.
  • Complete blood picture (Hemoglobin, White blood count (TLC), Platelet count).
  • Procalcitonin.
  1. Radiological examination that helps to detect source of sepsis included:
  • Chest X-ray.
  • Ultrasound of the abdomen.
  • CT abdomen with contrast.
  • Echo.
  1. Sepsis workup:
  • Blood cultures from one central and two peripheral lines.
  • Sputum culture or mini bronchio-alveolar lavage.
  • Urine culture.
  • Culture from a known source like abscess or tissue.
  1. Management: Management of all sepsis patients will be done according to the latest survival sepsis campaign guidelines including fluid resuscitation, vasopressor support and antimicrobial therapy.
  2. 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.
Being tested
Blood samples, blood sample
Keywords
sepsis, procalcitonin, prognosis, platelet/total leukocytic count ratio, outcome, prognostic value, septic patients
Medical subject headings
Pneumonia, Bacterial, Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood samplesDiagnostic test

    blood sample for CBC and procalcitonin

  • blood sampleDiagnostic test

    blood sample for procalcitonin and CBC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mortality

    survival or death of the patient

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2025
  2. Study start27 Sep 2024
  3. Primary completion15 Feb 2025
  4. Study completion10 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
100 participants (actual)
Target duration
28 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06991686
Sponsor's protocol ID
FMASU MS 598/2024
Status last verified
May 2025
First submitted
19 May 2025
Last updated
18 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 34599691
  • 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.

    PubMed 33537527
  • 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.

    PubMed 21171879
  • 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.

    PubMed 25651736
  • 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.

    PubMed 31073502
  • 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.

    PubMed 31671729
  • 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.

    PubMed 30048332
  • 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.

    PubMed 31277048
  • 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.

    PubMed 29022217
  • 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.

    PubMed 34679578

Questions about this trial

What is this clinical trial studying?

An observational study of All Conditions Causing Sepsis and Pneumonia - Bacterial, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06991686, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.

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