Cerebrovascular Reactivity in Hepatic Encephalopathy

NCT ID: NCT01099293

Last Updated: 2012-05-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-09-30

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.

Conditions

Hepatic Encephalopathy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Cirrhosis, w/o hepatic encephalopathy

Patients with liver cirrhosis without hepatic encephalopathy by clinical (West-Haven), neurophysiological tests (PHES) nor Critical Flicker Frequency evidence.

No interventions assigned to this group

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.

No interventions assigned to this group

Cirrhosis, Hepatic encephalopathy I

Patients with cirrhosis and clinical evidence of hepatic encephalopathy with a West Haven score of I.

No interventions assigned to this group

Control

Healthy subjects willing to participate in the study

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Council of Science and Technology, Mexico

OTHER

Sponsor Role: collaborator

Secretaria de Salud, Mexico

OTHER_GOV

Sponsor Role: collaborator

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role: lead

Responsible Party

ALDO TORRE DELGADILLO

M.D. M.Sc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aldo Torre-Delgadillo, M.D., M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Locations

Instituto Nacional de Ciencia Medicas de Nutricion Salvador Zubiran

México, State of Mexico, Mexico

Countries

Mexico

Other Identifiers

GAS-100-09/10-1

Identifier Type: -

Identifier Source: org_study_id