Cerebrovascular Reactivity in Hepatic Encephalopathy

Completed

• Conditions: Hepatic Encephalopathy

• Registration Number: NCT01099293
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-30
• Study First Submitted QC: 2010-04-05
• Study First Posted: 2010-04-06
• Primary Completion: 2011-06
• Study Completion: 2011-09
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-17
• Last Update Posted: 2012-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impaired cerebrovascular reactivity identified with transcranial Doppler ultrasonography of the Media Cerebral Artery.	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).

Secondary Outcome Measures

Name	Time	Method
Minimal Hepatic encephalopathy identified with psychometric hepatic encephalopathy score (PHES) and Critical Flicker Frequency (CFF).	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).
Hepatic encephalopathy stage I identified clinically and PHES and CFF.	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).
Blood samples to measure ammonium, , renin-angiotensin-aldosterone system, endotoxemia and Sb100	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).

Trial Locations

Locations (1)

Instituto Nacional de Ciencia Medicas de Nutricion Salvador Zubiran; 🇲🇽 Mexico, Mexico