Clinical Trial: Cerebrovascular Reactivity in Hepatic Encephalopathy

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Correlation Between Cerebrovascular Reactivity and Hepatic Encephalopathy in Patients With Cirrhosis

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 Summary: 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.
Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Current Primary Outcome: Impaired cerebrovascular reactivity identified with transcranial Doppler ultrasonography of the Media Cerebral Artery. [ Time Frame: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Dates:
Date Received: March 30, 2010
Date Started: March 2010
Date Completion:
Last Updated: May 17, 2012
Last Verified: May 2012