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

• Conditions: Spontaneous Bacterial Peritonitis
• Interventions: Other: serum amyloid A level

• Registration Number: NCT02759497
• Lead Sponsor: Tanta University

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

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 Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-05-01
• Study First Submitted QC: 2016-05-01
• Study First Posted: 2016-05-03
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-17
• Last Update Posted: 2017-06-20
• Primary Completion: 2020-10
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Serum amyloid A level in SBP	serum amyloid A level	serum amyloid A level
Serum amyloid A level in cirrhosis	serum amyloid A level	Serum amyloid A level

Primary Outcome Measures

Name	Time	Method
Number of patients with elevated serum amyloid A	6months

Trial Locations

Locations (1)

Sherief Abd-Elsalam; 🇪🇬 Cairo, Egypt