- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05399225
Platelets to Lymphocytes Ratio in Sepsis
Comparison Between Platelets to Lymphocytes Ratio and Procalcitonin in Prediction of Sepsis Outcome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sepsis is a rapidly progressive, life-threatening disease. Accurate and expeditious assessment of sepsis is important for early administration of antibiotics and removal of the source of infection.
In the 2016 version of the sepsis guidelines (Sepsis-3), the concept of the systemic inflammatory response syndrome has been deleted.
Although most patients with sepsis receive intensive management, such as early goal directed therapy (EGDT), in an emergency department (ED), the mortality rate of sepsis has been reported to be greater than 20% to 30%.
Many clinicians have studied the usefulness of blood biomarkers such as C-reactive protein, procalcitonin, and lactate for early assessment of sepsis and for prognostication, in order to initiate timeous treatment and to prevent rapid progression to multi-organ failure.
Several studies mentioned the advantages of the precursor molecule of calcitonin, namely procalcitonin as a biomarker for sepsis.
In recent years, studies have reported that platelets and lymphocytes play critical roles in the inflammatory process. Therefore, the platelet-to-lymphocyte ratio (PLR) a novel inflammatory factor has received research attention recently, as it may act as an indicator of inflammation, in a wide spectrum of diseases, such as myocardial infarction,acute kidney injury (AKI), Based on the findings of previous studies, it is reasonable to speculate the presence of a potential relationship between PLR and mortality for sepsis.
Platelet to lymphocytes ratio is defined as the ratio of the absolute platelet count and absolute lymphocyte count.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mohamed Ahmed Malah
- Phone Number: 01094844793
- Email: Mohamed.elmalah2@med.tanta.edu.eg
Study Locations
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Tanta, Egypt, 31511
- Recruiting
- Tanta university of medicine
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Contact:
- Ghada Fouad Elbaradey, Professor
- Phone Number: 01279588105
- Email: ghada.elbaradi@med.tanta.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Septic patients according to Third International Consensus Definitions for Sepsis
- with ICU stay more than 24 hours will be included.
Exclusion Criteria:
- Pregnant and women in puerperium.
- Patients with active hemorrhage
- Patients with hematological diseases (including bone marrow diseases) and collagen diseases.
- Patients on corticosteroid therapy or immunosuppressive drugs.
- Patients who will need immediate surgical interventions.
- Acute cerebrovascular or coronary syndrome.
- Patients received blood or platelets transfusion before enrollment in the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Platelets to lymphocytes ratio and procalcitonin
Platelets to lymphocytes ratio in patients with sepsis
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Platelets to lymphocytes ratio and procalcitonin in sepsis
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Procalcitonin group
Procalcitonin in patient with sepsis
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Platelets to lymphocytes ratio and procalcitonin in sepsis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The prediction of 28 days mortality.
Time Frame: during 28 days from patient admission till patient discharge or death.
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Prediction of 28 days mortality in icu patients with sepsis according to change in platlet to lymphocyte ratio
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during 28 days from patient admission till patient discharge or death.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of icu stay
Time Frame: throught study comletion, maximum 28 days
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number of days that past during patient presence in ICU
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throught study comletion, maximum 28 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Platelets to lymphocytes ratio
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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