Cerebrovascular Reactivity in Hepatic Encephalopathy

Hepatic Encephalopathy Clinical Trial

Official title:

Correlation Between Cerebrovascular Reactivity and Hepatic Encephalopathy in Patients With Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01099293
• Other study ID #: GAS-100-09/10-1
• Status: Completed
• Phase: N/A
• First received: March 30, 2010
• Last updated: May 17, 2012
• Start date: March 2010
• Est. completion date: September 2011

Study information

• Verified date: May 2012
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencia Medicas de Nutricion Salvador Zubiran	Mexico

Sponsors (3)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	National Council of Science and Technology, Mexico, Secretaria de Salud, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Minimal Hepatic encephalopathy identified with psychometric hepatic encephalopathy score (PHES) and Critical Flicker Frequency (CFF).	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)	No
Secondary	Hepatic encephalopathy stage I identified clinically and PHES and CFF.	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 motnhs)	No
Secondary	Blood samples to measure ammonium, , renin-angiotensin-aldosterone system, endotoxemia and Sb100	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 (3 months)	No