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

NCT ID: NCT02759497

Last Updated: 2017-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2020-11-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Spontaneous Bacterial Peritonitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Serum amyloid A level in SBP

serum amyloid A level

serum amyloid A level

Intervention Type OTHER

serum amyloid A level (SAA)

Serum amyloid A level in cirrhosis

Serum amyloid A level

serum amyloid A level

Intervention Type OTHER

serum amyloid A level (SAA)

Interventions

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serum amyloid A level

serum amyloid A level (SAA)

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

Consultant liver and GIT diseases- Tanta university hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rehab Badawi, Consultant

Role: PRINCIPAL_INVESTIGATOR

Hepatology and gastroenterology dept.-Tanta

Sherief Abd-Elsalam, Consultant

Role: STUDY_CHAIR

Division of Gastroenterology and Hepatology- Tanta

Walaa Elkhalawany, Consultant

Role: STUDY_CHAIR

Hepatology and gastroenterology dept.-Tanta

Reham Elkhouly, Consultant

Role: STUDY_CHAIR

Hepatology and gastroenterology dept.-Tanta

Mona Watany, Consultant

Role: STUDY_CHAIR

clinical pathology dept.-Tanta

Samah Soliman, Consultant

Role: STUDY_CHAIR

Hepatology and gastroenterology dept.-Tanta

Mai Khalaf, resident

Role: STUDY_CHAIR

hepatology dept.-Tanta

Locations

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Sherief Abd-Elsalam

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sherief Abd-Elsalam, Consultant

Role: CONTACT

00201095159522

Facility Contacts

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Sherief Abd-elsalam, lecturer

Role: primary

00201000040794

Other Identifiers

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sbp diagnosis

Identifier Type: -

Identifier Source: org_study_id

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