Evaluation of Mechanisms Responsible for Coma in Patients Affected by Fulminant, Acute and Chronic Hepatic Failure

July 21, 2023 updated by: The University of Texas Medical Branch, Galveston
The purpose of this study is to understand mechanisms associated with the development of coma during hepatic failure. As of today, those mechanisms are not understood and it is difficult to intervene and prevent coma development which is often associated with mortality. Understanding the mechanism involved, may allow us to prevent coma and develop new therapies to treat this disease.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

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

Study Locations

  • United States
    • Texas
      • Galveston, Texas, United States, 77555
        • The University of Texas Medical Branch

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

Sampling Method

Probability Sample

Study Population

GI clinic hospital inpatient stay

Description

Inclusion Criteria:

  • Patients (male or female), 18 years or older hospitalized or seen at UTMB clinics for chronic or acute hepatic failure will be included in the study.

Exclusion Criteria:

  • Patients (male or female), 18 years or older hospitalized or seen at UTMB clinics that do not have a diagnosis of chronic or acute hepatic failure

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

Cohorts and Interventions

Group / Cohort
acute or chronic hepatic failure
All patients presenting at University of Texas Medical Branch (UTMB) with acute and chronic hepatic failure and who are developing coma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The relationship that exist between a liver undergoing chronic or acute degeneration and hepatic coma.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

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

Sponsor

The University of Texas Medical Branch, Galveston

Investigators

  • Principal Investigator: Luca Cicalese, MD, The University of Texas Medical Branch

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)

February 1, 2012

Primary Completion (Actual)

July 24, 2018

Study Completion (Actual)

July 24, 2018

Study Registration Dates

First Submitted

April 18, 2012

First Submitted That Met QC Criteria

April 18, 2012

First Posted (Estimated)

April 20, 2012

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-030

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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