Platelets to Lymphocytes Ratio SepsisNCT05399225
Platelets to Lymphocytes Ratio in Sepsis
An observational study of Platelets to Lymphocytes Ratio Sepsis, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare effectiveness of platelets to lymphocytes ratio (PLR) with procalcitonin as a predictor of sepsis outcome. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Platelets to Lymphocytes Ratio Sepsis
- What is being tested?
- Platelets to lymphocytes ratio and procalcitonin
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2022to Jun 2023
- How long will I take part?
- 1 Year
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cross sectional
Who may be able to join
- Septic patients according to Third International Consensus Definitions for Sepsis
- with ICU stay more than 24 hours will be included.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta university of medicine
Tanta, 31511
Ghada Fouad Elbaradey, Professor, 01279588105, ghada.elbaradi@med.tanta.edu.eg
About this study
Official title: Comparison Between Platelets to Lymphocytes Ratio and Procalcitonin in Prediction of Sepsis Outcome
The aim of this study is to compare effectiveness of platelets to lymphocytes ratio (PLR) with procalcitonin as a predictor of sepsis outcome.
Read the 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.
- Conditions
- Platelets to Lymphocytes Ratio Sepsis
- Being tested
- Platelets to lymphocytes ratio and procalcitonin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelets to lymphocytes ratio and procalcitoninDiagnostic test
Platelets to lymphocytes ratio and procalcitonin in sepsis
| Study group | Role | What they receive |
|---|---|---|
| Platelets to lymphocytes ratio and procalcitonin | Platelets to lymphocytes ratio in patients with sepsis Receives: Diagnostic Test: Platelets to lymphocytes ratio and procalcitonin | |
| Procalcitonin group | Procalcitonin in patient with sepsis Receives: Diagnostic Test: Platelets to lymphocytes ratio and procalcitonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prediction of 28 days mortality.
Prediction of 28 days mortality in icu patients with sepsis according to change in platlet to lymphocyte ratio
Measured: during 28 days from patient admission till patient discharge or death.
Secondary outcomes (1)
Length of icu stay
number of days that past during patient presence in ICU
Measured: throught study comletion, maximum 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study startSep 2022 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelets to Lymphocytes Ratio SepsisStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Elmalah, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399225
- Sponsor's protocol ID
- Platelets to lymphocytes ratio
- Status last verified
- May 2022
- First submitted
- 28 Aug 2021
- Last updated
- 1 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Platelets to Lymphocytes Ratio and Procalcitonin in Prediction of Sepsis Outcome
- ClinicalTrials.gov ID
- NCT05399225
- Acronym / sponsor ID
- Platelets to lymphocytes ratio
- Conditions
- Platelets to Lymphocytes Ratio Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare effectiveness of platelets to lymphocytes ratio (PLR) with procalcitonin as a predictor of sepsis outcome.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelets to lymphocytes ratio and procalcitonin | – | Diagnostic Test: Platelets to lymphocytes ratio and procalcitoninPlatelets to lymphocytes ratio in patients with sepsis |
| Procalcitonin group | – | Diagnostic Test: Platelets to lymphocytes ratio and procalcitoninProcalcitonin in patient with sepsis |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cross sectional
Key inclusion criteria (2 listed)
- Septic patients according to Third International Consensus Definitions for Sepsis
- with ICU stay more than 24 hours will be included.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelets to lymphocytes ratio and procalcitoninPlatelets to lymphocytes ratio and procalcitonin in sepsis | Diagnostic test | Platelets to lymphocytes ratio and procalcitonin, Procalcitonin group |
Primary outcome
The prediction of 28 days mortality.
Time frame: 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
1 secondary outcome
Length of icu stay
Time frame: throught study comletion, maximum 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Platelets to Lymphocytes Ratio Sepsis, run by Tanta 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 1 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Ahmed Malah (01094844793, Mohamed.elmalah2@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prediction of 28 days mortality. (time frame: during 28 days from patient admission till patient discharge or death.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2022.