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Status unknownNCT02759497Updated Jun 20, 2017

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

An observational study in Spontaneous Bacterial Peritonitis, sponsored by Tanta University. Status unknown at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2017-06-20.

Sponsored by Tanta University · Observational

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
100
Sex
All
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Study 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

Read the 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.

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Conditions studied

  • Spontaneous Bacterial Peritonitis

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03

In context

Peritonitis

185 studies on the registry are indexed under Peritonitis; 25 are open to participants now.

This study's planned enrollment of 100 is below the median of 127 across 59 observational studies indexed under Peritonitis.

Browse Peritonitis studies →

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Decompensated cirrhosis with SBP Decompensated cirrhosis without SBP

Inclusion criteria

    • Decompansated cirrhosis with ascites, defined by a combination of any of the following:

      • Laboratory findings
      • Endoscopic results
      • Ultrasound
      • Histology

Exclusion criteria

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.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Serum amyloid A level in SBP

    serum amyloid A level

    Other: serum amyloid A level

  • Serum amyloid A level in cirrhosis

    Serum amyloid A level

    Other: serum amyloid A level

Interventions

  • Otherserum amyloid A level

    serum amyloid A level (SAA)

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What researchers measure

Primary outcomes

  1. Number of patients with elevated serum amyloid A

    Time frame: 6months

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Study locations

1 of 1 sites recruiting
  • Sherief Abd-Elsalam
    Cairo, Egypt
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02759497
Lead sponsor
Tanta University
Responsible party
Sherief Abd-Elsalam (Consultant liver and GIT diseases- Tanta university hospital, Tanta University) — Principal investigator
First posted
May 3, 2016
Start date
Mar 2016
Primary completion
Oct 2020 (estimated)
Completion
Nov 2020 (estimated)
Last update
Jun 20, 2017

Study contacts

Sherief Abd-Elsalam, Consultant
Contact
sheriefabdelsalam@yahoo.com
00201095159522
Rehab Badawi, Consultant
principal investigator · Hepatology and gastroenterology dept.-Tanta
Sherief Abd-Elsalam, Consultant
study chair · Division of Gastroenterology and Hepatology- Tanta
Walaa Elkhalawany, Consultant
study chair · Hepatology and gastroenterology dept.-Tanta
Reham Elkhouly, Consultant
study chair · Hepatology and gastroenterology dept.-Tanta
Mona Watany, Consultant
study chair · clinical pathology dept.-Tanta
Samah Soliman, Consultant
study chair · Hepatology and gastroenterology dept.-Tanta
Mai Khalaf, resident
study chair · hepatology dept.-Tanta

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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