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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01099293 |
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Date of registration:
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30/03/2010 |
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Primary sponsor: |
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Public title:
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Cerebrovascular Reactivity in Hepatic Encephalopathy
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Scientific title:
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Correlation Between Cerebrovascular Reactivity and Hepatic Encephalopathy in Patients With Cirrhosis |
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Date of first enrolment:
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March 2010 |
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Target sample size:
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90 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01099293 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Cross-Sectional
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Aldo Torre-Delgadillo, M.D., M.Sc. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
69 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hepatic Encephalopathy
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Primary Outcome(s)
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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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Secondary Outcome(s)
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Blood samples to measure ammonium, , renin-angiotensin-aldosterone system, endotoxemia and Sb100
[Time Frame: At time of recruitment (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)]
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Minimal Hepatic encephalopathy identified with psychometric hepatic encephalopathy score (PHES) and Critical Flicker Frequency (CFF).
[Time Frame: At time of recruitment (first 3 months)]
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Secondary ID(s)
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GAS-100-09/10-1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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