Risk Factors of Spontaneous Fungal Peritonitis in Cirrhotic Patients

May 10, 2023 updated by: Mona Mohammed Abdelrhman, Sohag University

Spontaneous bacterial peritonitis (SBP) is an infection of the peritoneal cavity with no surgically treatable intra-abdominal source of infection. Spontaneous peritonitis is a potentially fatal complication in patients with advanced liver cirrhosis. It is estimated that 10-20 % of patients with cirrhotic ascites may develop spontaneous peritonitis, which is usually caused by a bacterial infection.

In contrast, spontaneous fungal peritonitis (SFP) is less well-recognized. SFP may be associated with higher mortality rates than SBP but therapeutic approaches are largely undefined. To this end, the epidemiology and outcomes of patients with SFP have only been documented sporadically aimed to evaluate the risk factors for the development of spontaneous fungal peritonitis (SFP), and the prognosis of SFP compared with SBP

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cross-sectional study

Studied population & locality:

Patients with signs and symptoms suggestive of spontaneous peritonitis who will be admitted to Tropical medicine and Gastroenterology or Internal medicine departments in Sohag university hospitals during the period from september 2021 to december 2022 will be included in the study.

According to the results of ascitic fluid analysis, we will divide the patients into 2 groups:

Group (1): patients with spontaneous bacterial peritonitis (SBP). Group (2): patients with spontaneous fungal peritonitis (SFP).

Exclusion criteria:

Patients seropositive for human immunodeficiency virus (HIV) and patients undergoing continuous ambulatory peritoneal dialysis were excluded from this study.

Methods:

All included patients will be subjected to:

  1. Detailed history, complete general and systemic examination.
  2. Ascitic fluid analysis
  3. Bacterial and fungal culture from ascitic fluid:
  4. Laboratory investigations:

Fasting blood sugar Liver function tests. CBC.

Ethical considerations:

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Sohag, Egypt
        • Mona Mohammed Abdelrahman

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with signs and symptoms suggestive of spontaneous peritonitis who will be admitted to Tropical medicine and Gastroenterology or Internal medicine departments in Sohag university hospitals

Description

Inclusion Criteria:

Patients with signs and symptoms suggestive of spontaneous peritonitis who will be admitted to Tropical medicine and Gastroenterology or Internal medicine departments in Sohag university hospitals during the period from September 2021 to december 2022

Exclusion Criteria:

Patients seropositive for human immunodeficiency virus (HIV) and patients undergoing continuous ambulatory peritoneal dialysis were excluded from this study.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
spontaneous bacterial peritonitis
cirrhotic patients diagnosed with SBP
Diagnostic test: ASCITIC FLUID CULTURE
Ten milliliters of ascitic fluid will be collected at the bedside and inoculated into aerobic and anaerobic blood culture bottles. Bacterial culture will be performed manually using MacConkey and blood agar plate
spontaneous fungal peritonitis
irrhotic patients diagnosed with SFP
Diagnostic test: ASCITIC FLUID CULTURE
Ten milliliters of ascitic fluid will be collected at the bedside and inoculated into aerobic and anaerobic blood culture bottles. Bacterial culture will be performed manually using MacConkey and blood agar plate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
he risk factors for the development of spontaneous fungal peritonitis
Time Frame: September 2021 to December 2022 will be included in the study.
number/percentage
September 2021 to December 2022 will be included in the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Study Chair: Radwa Farag, MD, Sohag University
  • Study Chair: osamaa orabi, MD, Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 1, 2021

Primary Completion (Actual)

March 30, 2023

Study Completion (Actual)

April 29, 2023

Study Registration Dates

First Submitted

November 1, 2021

First Submitted That Met QC Criteria

November 1, 2021

First Posted (Actual)

November 11, 2021

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-10-53

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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