Blood Ammonia as Predictor for Esophageal Varices and Risk of Bleeding (EV)

July 7, 2017 updated by: Ferial El-Kalla, Tanta University

Evaluation of Blood Ammonia Level as a Non Invasive Predictor for Presence of Gastroesophageal Varices and Risk of Bleeding

Assessment of blood ammonia level as a non-invasive predictor for presence of EV and risk of bleeding

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A prospective cross sectional study on 150 consecutive patients screening for esophageal varices.

Patient groups groups:

Group (1): 100 patients with esophageal varices

Group (2): 50 chronic liver disease patients with no esophageal varices as a control group.

All patients will be subjected to:

  1. - Detailed history-taking
  2. - Full clinical examination

  3. - Laboratory investigations:

    • Complete blood picture (CBC)
    • Erythrocyte sedimentation rate (ESR)
    • Renal function tests
    • Liver function tests
    • Prothrombin time and activity
    • Viral markers (HCV Ab - HBV Ag)
    • Blood ammonia level.
  4. - Pelviabdominal US: Ultrasound examination of the liver, portal venous system, spleen, kidney and other abdominal organs.

  5. - Upper GITendoscopy:

    • Varices will be classified according to the Japanese classification 1996,
    • The Baveno 11 score will be used to differentiate between mild and severe portal hypertensive gastropathy.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Gharbiah
      • Tanta, Gharbiah, Egypt, 35127
        • Recruiting
        • Tanta faculty of medicine
        • Contact:
        • Sub-Investigator:
          • Loai Mansour, MD
        • Sub-Investigator:
          • Abdelrahman Kobtan, MD
        • Sub-Investigator:
          • Asmaa Elziftawy, MBBCH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with chronic liver disease

Exclusion Criteria:

  • Patient in hepatic encephalopathy or coma.
  • Patient in active bleeding or with history of bleeding within the two weeks prior to entry in the study .
  • Patients with heart failure.
  • Patients with renal failure.
  • Patient with hepatocellular carcinoma and portal vein thrombosis.
  • Patient taking Beta blockers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Endoscopy
Diagnostic test: Endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
level of serum ammonia in patients with risk factors for bleeding from esophageal varices
Time Frame: 24 months
estimation of level of serum ammonia in patients with risk factors for bleeding from esophageal varices
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Ferial El-Kalla, MD, Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2016

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

July 7, 2017

First Submitted That Met QC Criteria

July 7, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

July 11, 2017

Last Update Submitted That Met QC Criteria

July 7, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30142/03/31

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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