- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01099293
Cerebrovascular Reactivity in Hepatic Encephalopathy
Correlation Between Cerebrovascular Reactivity and Hepatic Encephalopathy in Patients With Cirrhosis
It has been observed that patients with cirrhosis present a generalized state of vasoconstriction as an homeostatic response to splanchnic arteriolar vasodilatation. On progression of the disease, vascular regulation is mismatched, causing altered systemic blood flow and lose in the cerebrovascular reactivity.
The investigators hypothesize that the altered cerebrovascular reactivity induces neurological disturbances related to hepatic encephalopathy and, therefore, the existence of a correlation between cerebrovascular reactivity and the stage of hepatic encephalopathy.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Mexico, Mexico, 14000
- Instituto Nacional de Ciencia Medicas de Nutricion Salvador Zubiran
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
The population from which the cohorts will be selected are from a hospital care population.
Control group will be selected from the health personal by invitation to volunteer.
Description
Inclusion Criteria:
- Clinical diagnosis of Liver Cirrhosis
Exclusion Criteria:
- Personal history of surgery in the last 4 weeks
- Diagnosis of Diabetes Mellitus, Hypertension, COPD or liver metabolic diseases (Wilson's disease and hemochromatosis)
- Personal history of stroke and/or cancer
- Use of neuropsychiatric drugs
- Neuropsychiatric disorders (Schizophrenia, bipolar disorder, dementia and Attention-deficit hyperactivity disorder)
- Thyroid disorders without replacement therapy
- Hepatic or renal transplant
- Alcoholism with active ingest of alcohol in the last 6 months
- Pregnancy
- Labour turn-overs
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Cirrhosis, w/o hepatic encephalopathy
Patients with liver cirrhosis without hepatic encephalopathy by clinical (West-Haven), neurophysiological tests (PHES) nor Critical Flicker Frequency evidence.
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Cirrhosis-minimal hepatic encephalopathy
Patients with cirrhosis, without clinical evidence of hepatic encephalopathy (West Haven 0) and with positive tests for both, PHES and CFF.
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Cirrhosis, Hepatic encephalopathy I
Patients with cirrhosis and clinical evidence of hepatic encephalopathy with a West Haven score of I.
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Control
Healthy subjects willing to participate in the study
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impaired cerebrovascular reactivity identified with transcranial Doppler ultrasonography of the Media Cerebral Artery.
Time Frame: At time of recruitment (first 3 months)
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Recruitment period is planned for the first 3 months of the study, where outcome messures will be evaluated in a single and unique ocassion, at the time of subject enrollment, due to the characteristics of the study (cross-sectional).
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At time of recruitment (first 3 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Minimal Hepatic encephalopathy identified with psychometric hepatic encephalopathy score (PHES) and Critical Flicker Frequency (CFF).
Time Frame: At time of recruitment (first 3 months)
|
Recruitment period is planned for the first 3 months of the study, where outcome messures will be evaluated in a single and unique ocassion, at the time of subject enrollment, due to the characteristics of the study (cross-sectional).
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At time of recruitment (first 3 months)
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Hepatic encephalopathy stage I identified clinically and PHES and CFF.
Time Frame: At time of recruitment (first 3 motnhs)
|
Recruitment period is planned for the first 3 months of the study, where outcome messures will be evaluated in a single and unique ocassion, at the time of subject enrollment, due to the characteristics of the study (cross-sectional).
|
At time of recruitment (first 3 motnhs)
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Blood samples to measure ammonium, , renin-angiotensin-aldosterone system, endotoxemia and Sb100
Time Frame: At time of recruitment (3 months)
|
Recruitment period is planned for the first 3 months of the study, where outcome messures will be evaluated in a single and unique ocassion, at the time of subject enrollment, due to the characteristics of the study (cross-sectional).
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At time of recruitment (3 months)
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Collaborators and Investigators
Investigators
- Principal Investigator: Aldo Torre-Delgadillo, M.D., M.Sc., Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GAS-100-09/10-1
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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