Evaluation of Serum Amyloid A in Early Diagnosis of Spontaneous Bacterial Peritonitis
1 other identifier
observational
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 1, 2016
CompletedFirst Posted
Study publicly available on registry
May 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedJune 20, 2017
June 1, 2017
4.6 years
May 1, 2016
June 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients with elevated serum amyloid A
6months
Study Arms (2)
Serum amyloid A level in SBP
serum amyloid A level
Serum amyloid A level in cirrhosis
Serum amyloid A level
Interventions
serum amyloid A level (SAA)
Eligibility Criteria
Decompensated cirrhosis with SBP Decompensated cirrhosis without SBP
You may qualify if:
- Decompansated cirrhosis with ascites, defined by a combination of any of the following:
- Laboratory findings
- Endoscopic results
- Ultrasound
- Histology
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Sherief Abd-Elsalam
Cairo, Egypt
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant liver and GIT diseases- Tanta university hospital
Study Record Dates
First Submitted
May 1, 2016
First Posted
May 3, 2016
Study Start
March 1, 2016
Primary Completion
October 1, 2020
Study Completion
November 1, 2020
Last Updated
June 20, 2017
Record last verified: 2017-06