Evaluation of Serum Amyloid A in Early Diagnosis of Spontaneous Bacterial Peritonitis

June 17, 2017 updated by: Sherief Abd-Elsalam, Tanta University

One of the most common and serious complications in decompensated cirrhotic patients (DCPs) is bacterial infection.The most common infections in DCPs are cases of spontaneous bacterial peritonitis (SBP), which account for 40% 70% of cases, followed by urinary tract infections, pneumonia and cellulitis.

Serum amyloid A (SAA) and C-reactive protein (CRP) are acute-phase proteins predominantly produced and secreted by hepatocytes. Other cells including lymphocytes, monocytes, and macrophages can also produce these proteins. The induction of SAA and CRP synthesis is triggered by a number of cytokines, chiefly IL-6, which is released from a variety of cell types, but mainly from macrophages and monocytes at inflammatory sites

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Increased serum CRP and SAA levels have been found in a number of disorders, including bacterial infections, malignancies tissue injuries and tissue rejection. Therefore, new studies of early diagnosis, prevention and treatment are needed to improve clinical outcomes.

Study Type

Observational

Enrollment (Anticipated)

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 Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Sherief Abd-Elsalam

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

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Decompensated cirrhosis with SBP Decompensated cirrhosis without SBP

Description

Inclusion Criteria:

  • • Decompansated cirrhosis with ascites, defined by a combination of any of the following:

    • Laboratory findings
    • Endoscopic results
    • Ultrasound
    • Histology

Exclusion Criteria:

  • Creatinine>1.5 mg/dl
  • Other infection e.grespiratory,UTI ,gastrointestinal and skin infection.
  • Hepatocellular carcinoma
  • Other extrahepatic malignancy e.g ; chest
  • Any significant psychiatric illness or other medical comorbidity.
  • Any degenerative 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
Serum amyloid A level in SBP
serum amyloid A level
Other: serum amyloid A level
serum amyloid A level (SAA)
Serum amyloid A level in cirrhosis
Serum amyloid A level
Other: serum amyloid A level
serum amyloid A level (SAA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with elevated serum amyloid A
Time Frame: 6months
6months

Collaborators and Investigators

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

Sponsor

Tanta University

Investigators

  • Study Chair: Walaa Elkhalawany, Consultant, Hepatology and gastroenterology dept.-Tanta
  • Study Chair: Mona Watany, Consultant, clinical pathology dept.-Tanta
  • Principal Investigator: Rehab Badawi, Consultant, Hepatology and gastroenterology dept.-Tanta
  • Study Chair: Sherief Abd-Elsalam, Consultant, Division of Gastroenterology and Hepatology- Tanta
  • Study Chair: Reham Elkhouly, Consultant, Hepatology and gastroenterology dept.-Tanta
  • Study Chair: Samah Soliman, Consultant, Hepatology and gastroenterology dept.-Tanta
  • Study Chair: Mai Khalaf, resident, Hepatology dept.-Tanta

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

March 1, 2016

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

May 1, 2016

First Submitted That Met QC Criteria

May 1, 2016

First Posted (Estimate)

May 3, 2016

Study Record Updates

Last Update Posted (Actual)

June 20, 2017

Last Update Submitted That Met QC Criteria

June 17, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sbp diagnosis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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