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

Sponsor
Tanta University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02759497
Collaborator
(none)
100
1
56
1.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: serum amyloid A level

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Evaluation of Serum Amyloid A in Early Diagnosis of Spontaneous Bacterial Peritonitis
Study Start Date :
Mar 1, 2016
Anticipated Primary Completion Date :
Oct 1, 2020
Anticipated Study Completion Date :
Nov 1, 2020

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. Number of patients with elevated serum amyloid A [6months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sherief Abd-Elsalam Cairo Egypt

Sponsors and Collaborators

  • Tanta University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sherief Abd-Elsalam, Consultant liver and GIT diseases- Tanta university hospital, Tanta University
ClinicalTrials.gov Identifier:
NCT02759497
Other Study ID Numbers:
  • sbp diagnosis
First Posted:
May 3, 2016
Last Update Posted:
Jun 20, 2017
Last Verified:
Jun 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 20, 2017