Platelets to Lymphocytes Ratio in Sepsis

Sponsor
Tanta University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05399225
Collaborator
(none)
50
1
9
5.6

Study Details

Study Description

Brief Summary

The aim of this study is to compare effectiveness of platelets to lymphocytes ratio (PLR) with procalcitonin as a predictor of sepsis outcome.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Platelets to lymphocytes ratio and procalcitonin

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparison Between Platelets to Lymphocytes Ratio and Procalcitonin in Prediction of Sepsis Outcome
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Platelets to lymphocytes ratio and procalcitonin

Platelets to lymphocytes ratio in patients with sepsis

Diagnostic Test: Platelets to lymphocytes ratio and procalcitonin
Platelets to lymphocytes ratio and procalcitonin in sepsis

Procalcitonin group

Procalcitonin in patient with sepsis

Diagnostic Test: Platelets to lymphocytes ratio and procalcitonin
Platelets to lymphocytes ratio and procalcitonin in sepsis

Outcome Measures

Primary Outcome Measures

  1. The prediction of 28 days mortality. [during 28 days from patient admission till patient discharge or death.]

    Prediction of 28 days mortality in icu patients with sepsis according to change in platlet to lymphocyte ratio

Secondary Outcome Measures

  1. Length of icu stay [throught study comletion, maximum 28 days]

    number of days that past during patient presence in ICU

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Septic patients according to Third International Consensus Definitions for Sepsis

  2. with ICU stay more than 24 hours will be included.

Exclusion Criteria:
  1. Pregnant and women in puerperium.

  2. Patients with active hemorrhage

  3. Patients with hematological diseases (including bone marrow diseases) and collagen diseases.

  4. Patients on corticosteroid therapy or immunosuppressive drugs.

  5. Patients who will need immediate surgical interventions.

  6. Acute cerebrovascular or coronary syndrome.

  7. Patients received blood or platelets transfusion before enrollment in the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tanta university of medicine Tanta Egypt 31511

Sponsors and Collaborators

  • Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Ahmed Elmalah, assistant lecturer, Tanta University
ClinicalTrials.gov Identifier:
NCT05399225
Other Study ID Numbers:
  • Platelets to lymphocytes ratio
First Posted:
Jun 1, 2022
Last Update Posted:
Jun 1, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 1, 2022