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Cerebrovascular Reactivity in Hepatic Encephalopathy

I

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status

Completed

Conditions

Hepatic Encephalopathy

Study type

Observational

Funder types

Other

Identifiers

NCT01099293
GAS-100-09/10-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

18 to 69 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

90 participants in 4 patient groups

Cirrhosis, w/o hepatic encephalopathy
Description:
Patients with liver cirrhosis without hepatic encephalopathy by clinical (West-Haven), neurophysiological tests (PHES) nor Critical Flicker Frequency evidence.
Cirrhosis-minimal hepatic encephalopathy
Description:
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
Description:
Patients with cirrhosis and clinical evidence of hepatic encephalopathy with a West Haven score of I.
Control
Description:
Healthy subjects willing to participate in the study

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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