MPV and NLR as Predictors of SBP Diagnosis

Sponsor

Sohag University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04775420

Collaborator

(none)

200

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Spontaneous Bacterial Peritonitis	Diagnostic Test: Measurement of mean platelet volume (MPV) and blood neutrophil to lymphocyte ratio (NLR)

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Mean Platelet Volume (MPV) and Neutrophil to Lymphocyte Ratio (NLR) as Predictors of Spontaneous Bacterial Peritonitis in Cirrhotic Patients

Anticipated Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

May 31, 2021

Anticipated Study Completion Date :

Jul 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Group 1 Ascetic patients without spontaneous bacterial peritonitis	Diagnostic Test: Measurement of mean platelet volume (MPV) and blood neutrophil to lymphocyte ratio (NLR) MPV and NLR are easily accessible and inexpensive tests
Group 2 Ascetic patients with spontaneous bacterial peritonitis	Diagnostic Test: Measurement of mean platelet volume (MPV) and blood neutrophil to lymphocyte ratio (NLR) MPV and NLR are easily accessible and inexpensive tests

Arm

Intervention/Treatment

Group 1

Ascetic patients without spontaneous bacterial peritonitis

Diagnostic Test: Measurement of mean platelet volume (MPV) and blood neutrophil to lymphocyte ratio (NLR)

MPV and NLR are easily accessible and inexpensive tests

Group 2

Ascetic patients with spontaneous bacterial peritonitis

Diagnostic Test: Measurement of mean platelet volume (MPV) and blood neutrophil to lymphocyte ratio (NLR)

MPV and NLR are easily accessible and inexpensive tests

Outcome Measures

Primary Outcome Measures

The utility of MPV as non-invasive predictor of SBP [1 year]
It will be measured from CBC
The utility of NLR as non-invasive predictor of SBP [1 year]
It will be measured from CBC

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Abudeif Abdelaal, MD, Principal Investigator, Sohag University

ClinicalTrials.gov Identifier:

NCT04775420

Other Study ID Numbers:

Soh-Med-21-02-22

First Posted:

Mar 1, 2021

Last Update Posted:

Mar 3, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ahmed Abudeif Abdelaal, MD, Principal Investigator, Sohag University

Spontaneous bacterial peritonitis

Mean platelet volume

Neutrophil to lymphocyte ratio

Additional relevant MeSH terms:

Peritonitis

Study Results

No Results Posted as of Mar 3, 2021