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

Spontaneous Bacterial Peritonitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02759497
• Other study ID #: sbp diagnosis
• Status: Recruiting
• Phase: N/A
• First received: May 1, 2016
• Last updated: June 17, 2017
• Start date: March 2016
• Est. completion date: November 2020

Study information

• Verified date: June 2017
• Source: Tanta University
• Contact: Sherief Abd-Elsalam, Consultant
• Phone: 00201095159522
• Email: sheriefabdelsalam[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Peritonitis
• Spontaneous Bacterial Peritonitis

Intervention

Other:
• serum amyloid A level
serum amyloid A level (SAA)

Locations

Country	Name	City	State
Egypt	Sherief Abd-Elsalam	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with elevated serum amyloid A		6months