Clinical trial NCT01099293: Cerebrovascular Reactivity in Hepatic Encephalopathy
Official title: Correlation Between Cerebrovascular Reactivity and Hepatic Encephalopathy in Patients With Cirrhosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatic Encephalopathy
Keywords: Hepatic Encephalopathy
Psychometric Hepatic Encephalopathy Score
Critical Flicker Frequency
Cerebrovascular Reactivity
Endotoxemia
Transcranial Doppler
Liver Cirrhosis
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
Collaborators: name: National Council of Science and Technology, Mexico
name: Secretaria de Salud, Mexico
First posted: 2010-04-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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.

Detailed description: There is no bibliography that evidenciates a correlation between cerebrovascular reactivity and the stage of hepatic encephalopathy. There are however, papers that reveal generalized systemic vasoconstriction in patients with cirrhosis and others that affirm the presence of vascular disregulation and altered reactivity in the Middle Cerebral Artery in cirrhotic patients. In the other hand, there is published data that correlates the neurological manifestations of diseases characterised by altered blood flow and cerebrovascular reactivity with the degree of the vascular disregulation itself, identified by US Doppler. However, there are no studies correlating transcranial US Doppler findings of cerebrovascular reactivity and hepatic encephalopathy in patients with cirrhosis. Giving its importance to the chance of revealing a new way of pathophysiology and therefore, early therapeutic management.

Eligibility criteria: 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

Primary outcomes:
measure: Impaired cerebrovascular reactivity identified with transcranial Doppler ultrasonography of the Media Cerebral Artery.
timeFrame: At time of recruitment (first 3 months)
Secondary outcomes:
measure: Minimal Hepatic encephalopathy identified with psychometric hepatic encephalopathy score (PHES) and Critical Flicker Frequency (CFF).
timeFrame: At time of recruitment (first 3 months)
measure: Hepatic encephalopathy stage I identified clinically and PHES and CFF.
timeFrame: At time of recruitment (first 3 motnhs)
measure: Blood samples to measure ammonium, , renin-angiotensin-aldosterone system, endotoxemia and Sb100
timeFrame: At time of recruitment (3 months)
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Instituto Nacional de Ciencia Medicas de Nutricion Salvador Zubiran
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Aldo Torre-Delgadillo, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: