NCT04775420

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
332

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

January 23, 2023

Status Verified

January 1, 2023

Enrollment Period

2.1 years

First QC Date

February 25, 2021

Last Update Submit

January 20, 2023

Conditions

Spontaneous Bacterial Peritonitis

Keywords

Spontaneous bacterial peritonitisMean platelet volumeNeutrophil to lymphocyte ratio

Outcome Measures

Primary Outcomes (2)

  • The utility of MPV as non-invasive predictor of SBP

    It will be measured from CBC

    1 year

  • The utility of NLR as non-invasive predictor of SBP

    It will be measured from CBC

    1 year

Study Arms (2)

Group 1

Ascetic patients without spontaneous bacterial peritonitis

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

Group 2

Ascetic patients with spontaneous bacterial peritonitis

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

Interventions

Measurement of mean platelet volume (MPV) and blood neutrophil to lymphocyte ratio (NLR)DIAGNOSTIC_TEST

MPV and NLR are easily accessible and inexpensive tests

Group 1Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Decompensated liver cirrhosis ascetic patients.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag Faculty of Medicine

Sohag, 82524, Egypt

Location

MeSH Terms

Interventions

Mean Platelet Volume

Intervention Hierarchy (Ancestors)

Platelet Function TestsHematologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesCell SizeCell Physiological Phenomena

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 1, 2021

Study Start

April 1, 2020

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

January 23, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)