- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04775420
MPV and NLR as Predictors of SBP Diagnosis
January 20, 2023 updated by: Ahmed Abudeif Abdelaal, MD, Sohag University
Mean Platelet Volume (MPV) and Neutrophil to Lymphocyte Ratio (NLR) as Predictors of Spontaneous Bacterial Peritonitis in Cirrhotic Patients
The aim of the study is to investigate the clinical utility of mean platelet volume (MPV) and neutrophil to lymphocyte ratio (NLR) as diagnostic markers for spontaneous bacterial peritonitis (SBP).
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
332
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Sohag, Egypt, 82524
- Sohag faculty of medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with ascites due to decompensated liver cirrhosis admitted at the inpatient section of Tropical Medicine and Gastroenterology Department, Sohag University Hospital.
Description
Inclusion Criteria:
- Decompensated liver cirrhosis ascetic patients.
Exclusion Criteria:
- Immunocompromised patients.
- Patients who had received antibiotics before hospital admission.
- Patients on anticoagulant medications, NSAIDs, or oral contraceptive drugs.
- Patients with heart failure, diabetes mellitus, hypertension, hyperlipidemia, peripheral vascular disease, hematological disorders, and neoplastic disorders and patients with clinically overt hypothyroidism or hyperthyroidism or with clinically and laboratory-evident autoimmune diseases.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1
Ascetic patients without spontaneous bacterial peritonitis
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MPV and NLR are easily accessible and inexpensive tests
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|
Group 2
Ascetic patients with spontaneous bacterial peritonitis
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MPV and NLR are easily accessible and inexpensive tests
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The utility of MPV as non-invasive predictor of SBP
Time Frame: 1 year
|
It will be measured from CBC
|
1 year
|
|
The utility of NLR as non-invasive predictor of SBP
Time Frame: 1 year
|
It will be measured from CBC
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2020
Primary Completion (Actual)
April 30, 2022
Study Completion (Actual)
April 30, 2022
Study Registration Dates
First Submitted
February 25, 2021
First Submitted That Met QC Criteria
February 26, 2021
First Posted (Actual)
March 1, 2021
Study Record Updates
Last Update Posted (Actual)
January 23, 2023
Last Update Submitted That Met QC Criteria
January 20, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-21-02-22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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