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

Purpose

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.

Condition
Acute and Chronic Hepatic Failure With Developing Coma

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Retrospective
Official Title:	Evaluation of Mechanisms Responsible for Coma in Patients Affected by Fulminant, Acute and Chronic Hepatic Failure

Resource links provided by NLM:

MedlinePlus related topics: Coma

U.S. FDA Resources

Further study details as provided by The University of Texas, Galveston:

Biospecimen Retention: Samples Without DNA

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

Estimated Enrollment:	20
Study Start Date:	February 2012

Groups/Cohorts
acute or chronic hepatic failure All patients presenting at UTMB with acute and chronic hepatic failure and who are developing coma

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

GI clinic hospital inpatient stay

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582087

Contacts

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

Locations

United States, Texas
The University of Texas Medical Branch	Recruiting
Galveston, Texas, United States, 77555
Contact: Luca Cicalese, MD 409-772-2405 lucicale@utmb.edu
Contact: Betty Shipp, RN 409-772-4896 bjshipp@utmb.edu
Principal Investigator: Luca Cicalese, MD

Sponsors and Collaborators

The University of Texas, Galveston

Investigators

Principal Investigator:

Luca Cicalese, MD

The University of Texas Medical Branch

More Information

No publications provided

Responsible Party:	The University of Texas, Galveston
ClinicalTrials.gov Identifier:	NCT01582087 History of Changes
Other Study ID Numbers:	12-030
Study First Received:	April 18, 2012
Last Updated:	April 18, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of Texas, Galveston:

acute hepatic failure
chronic hepatic failure
coma

Additional relevant MeSH terms:

Coma
Cogan Syndrome
Liver Failure
Liver Diseases
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases

Signs and Symptoms
Vestibulocochlear Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Hepatic Insufficiency
Digestive System Diseases

ClinicalTrials.gov processed this record on May 21, 2013

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