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

This study is currently recruiting participants.
Verified March 2014 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: March 19, 2014
Last verified: March 2014

April 18, 2012
March 19, 2014
February 2012
December 2014   (final data collection date for primary outcome measure)
The relationship that exist between a liver undergoing chronic or acute degeneration and hepatic coma. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT01582087 on ClinicalTrials.gov Archive Site
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Evaluation of Mechanisms Responsible for Coma in Patients Affected by Fulminant, Acute and Chronic Hepatic Failure
Evaluation of Mechanisms Responsible for Coma in Patients Affected by Fulminant, Acute and Chronic Hepatic Failure

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.

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Observational
Observational Model: Cohort
Time Perspective: Retrospective
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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.

Probability Sample

GI clinic hospital inpatient stay

Acute and Chronic Hepatic Failure With Developing Coma
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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
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December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Luca Cicalese, MD 409-772-2405 lucicale@utmb.edu
Contact: Betty Shipp, RN 409-772-4896 bjshipp@utmb.edu
United States
 
NCT01582087
12-030
Yes
The University of Texas, Galveston
The University of Texas, Galveston
Not Provided
Principal Investigator: Luca Cicalese, MD The University of Texas Medical Branch
The University of Texas, Galveston
March 2014

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