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Cerebrovascular Reactivity in Hepatic Encephalopathy

This study has been completed.
Sponsor:
Collaborators:
National Council of Science and Technology, Mexico
Secretaria de Salud, Mexico
Information provided by (Responsible Party):
ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT01099293
First received: March 30, 2010
Last updated: May 17, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition
Hepatic Encephalopathy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Correlation Between Cerebrovascular Reactivity and Hepatic Encephalopathy in Patients With Cirrhosis

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Further study details as provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:

Primary Outcome Measures:
  • Impaired cerebrovascular reactivity identified with transcranial Doppler ultrasonography of the Media Cerebral Artery. [ Time Frame: At time of recruitment (first 3 months) ] [ Designated as safety issue: No ]
    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:
  • Minimal Hepatic encephalopathy identified with psychometric hepatic encephalopathy score (PHES) and Critical Flicker Frequency (CFF). [ Time Frame: At time of recruitment (first 3 months) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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).


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.

Enrollment: 90
Study Start Date: March 2010
Study Completion Date: September 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01099293

Locations
Mexico
Instituto Nacional de Ciencia Medicas de Nutricion Salvador Zubiran
Mexico, Mexico, 14000
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
National Council of Science and Technology, Mexico
Secretaria de Salud, Mexico
Investigators
Principal Investigator: Aldo Torre-Delgadillo, M.D., M.Sc. Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  More Information

No publications provided

Responsible Party: ALDO TORRE DELGADILLO, M.D. M.Sc, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT01099293     History of Changes
Other Study ID Numbers: GAS-100-09/10-1
Study First Received: March 30, 2010
Last Updated: May 17, 2012
Health Authority: Mexico: Ethics Committee

Keywords provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Hepatic Encephalopathy
Psychometric Hepatic Encephalopathy Score
Critical Flicker Frequency
Cerebrovascular Reactivity
 Endotoxemia
Transcranial Doppler
Liver Cirrhosis

Additional relevant MeSH terms:
Hepatic Encephalopathy
Brain Damage, Chronic
Delirium
Encephalitis
Neurotoxicity Syndromes
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Metabolic Diseases
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on May 16, 2013