Blood Ammonia as Predictor for Esophageal Varices and Risk of Bleeding

Chronic Liver Disease Clinical Trial

— EV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03212872
• Other study ID #: 30142/03/31
• Status: Recruiting
• Phase: N/A
• First received: July 7, 2017
• Last updated: July 7, 2017
• Start date: July 7, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2017
• Source: Tanta University
• Contact: Ferial El-Kalla, MD
• Phone: 00201006023289
• Email: f.elkalla[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Liver Disease
• Esophageal and Gastric Varices
• Esophageal Varices
• Hemorrhage
• Liver Diseases
• Varicose Veins

Intervention

Diagnostic Test:
• Endoscopy

Locations

Country	Name	City	State
Egypt	Tanta Faculty of Medicine	Tanta	Gharbiah

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of serum ammonia in patients with risk factors for bleeding from esophageal varices	estimation of level of serum ammonia in patients with risk factors for bleeding from esophageal varices	24 months