Trial record 2 of 29 for:    Open Studies | "Coma"

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
  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:


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

Primary Outcome Measures:
  • The relationship that exist between a liver undergoing chronic or acute degeneration and hepatic coma. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

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
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  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: March 19, 2014
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
Liver Failure
Liver Diseases
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hepatic Insufficiency
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014