Cerebrovascular Reactivity in Hepatic Encephalopathy

NCT01099293 | Completed

• 1 other identifier: GAS-100-09/10-1
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Encephalopathy

Keywords

Hepatic Encephalopathy; Psychometric Hepatic Encephalopathy Score; Critical Flicker Frequency; Cerebrovascular Reactivity; Endotoxemia; Transcranial Doppler; Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Impaired cerebrovascular reactivity identified with transcranial Doppler ultrasonography of the Media Cerebral Artery.

  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 months)

Secondary Outcomes (3)

• Minimal Hepatic encephalopathy identified with psychometric hepatic encephalopathy score (PHES) and Critical Flicker Frequency (CFF).

  At time of recruitment (first 3 months)

• Hepatic encephalopathy stage I identified clinically and PHES and CFF.

  At time of recruitment (first 3 motnhs)

• Blood samples to measure ammonium, , renin-angiotensin-aldosterone system, endotoxemia and Sb100

  At time of recruitment (3 months)

Study Arms (4)

Cirrhosis, w/o hepatic encephalopathy

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

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.

Cirrhosis, Hepatic encephalopathy I

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

Control

Healthy subjects willing to participate in the study

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Clinical diagnosis of Liver Cirrhosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead
• National Council of Science and Technology, Mexico: collaborator
• Secretaria de Salud, Mexico: collaborator

Study Sites (1)

Instituto Nacional de Ciencia Medicas de Nutricion Salvador Zubiran

México, State of Mexico, 14000, Mexico

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

1. Patients with cirrhosis without hepatic encephalopathy. 2. Patients with cirrhosis and minimal hepatic encephalopathy. 3. Patients with cirrhosis and hepatic encephalopathy stage 1. 4. Healthy subjects willing to participate.

MeSH Terms

Conditions

Hepatic Encephalopathy; Endotoxemia; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Bacteremia; Sepsis; Infections; Toxemia; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis

Study Officials

• Aldo Torre-Delgadillo, M.D., M.Sc.

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. M.Sc

Study Record Dates

• First Submitted: March 30, 2010
• First Posted: April 6, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 21, 2012

Record last verified: 2012-05

Locations

ME (1)