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Completed

NCT Number: NCT01099293

Cerebrovascular Reactivity in Hepatic Encephalopathy

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.

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Key information

Conditions

Hepatic Encephalopathy Bacteremia Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Endotoxemia Fibrosis Hepatic Insufficiency Infections Inflammation Liver Cirrhosis Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Toxemia

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Nacional de Ciencia Medicas de Nutricion Salvador Zubiran

México, State of Mexico, 14000, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Collaborators

  • National Council of Science and Technology, Mexico
  • Secretaria de Salud, Mexico

Registry information

Official study title

Correlation Between Cerebrovascular Reactivity and Hepatic Encephalopathy in Patients With Cirrhosis

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 6, 2010
Registry last updated
May 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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