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

This study is currently recruiting participants.

Verified April 2012 by The University of Texas, Galveston

Sponsor:

Information provided by (Responsible Party):

The University of Texas, Galveston

ClinicalTrials.gov Identifier:

NCT01582087

First received: April 18, 2012

Last updated: NA

Last verified: April 2012

History: No changes posted

Tracking Information

First Received Date ^ICMJE

April 18, 2012

Last Updated Date

April 18, 2012

Start Date ^ICMJE

February 2012

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

Samples previously collected for diagnostic use which could include blood, urine, bile, cerebral spinal fluid, feces, liver tissue, brain tissue.

Sampling Method

Probability Sample

Study Population

GI clinic hospital inpatient stay

Condition ^ICMJE

Acute and Chronic Hepatic Failure With Developing Coma

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

acute or chronic hepatic failure

All patients presenting at UTMB with acute and chronic hepatic failure and who are developing coma

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Luca Cicalese, MD	409-772-2405	lucicale@utmb.edu
Contact: Betty Shipp, RN	409-772-4896	bjshipp@utmb.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01582087

Other Study ID Numbers ^ICMJE

12-030

Has Data Monitoring Committee

Yes

Responsible Party

The University of Texas, Galveston

Study Sponsor ^ICMJE

The University of Texas, Galveston

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Luca Cicalese, MD

The University of Texas Medical Branch

Information Provided By

The University of Texas, Galveston

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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