Bioelectrical Impedance Vector Analysis in Cirrhotic Patients (BIVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01603953
Recruitment Status : Completed
First Posted : May 23, 2012
Last Update Posted : November 18, 2014
Information provided by (Responsible Party):
ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief Summary:

Protein-energy malnutrition and muscle wasting are a common finding among patients with liver cirrhosis. Its prevalence may range from 50-90% depending on the methods used for nutritional assessment. Even stable cirrhotic patients referred as Child A have muscle depletion and the majority of patients classified as Child C have significant depletion. Malnutrition has been shown to be related to several complications of cirrhosis

Despite the importance of nutritional status in patient's outcome, there is no gold standard for nutritional assessment. Traditional techniques used in healthy subjects to assess nutritional status cannot be used in cirrhotic patients due especially to ascites and peripheral edema, and altered rates of biochemical markers due to liver failure.

Bioelectrical impedance vector analysis has emerged as a useful method to assess body composition and nutritional status especially in patients at the extremes of body weight (fluid overload, excess of adipose tissue, etc.).

The aim of this study is to evaluate whether malnutrition assessed by bioelectrical impedance vector analysis is related to the development of hepatic encephalopathy

Condition or disease
Cirrhosis Hepatic Encephalopathy

Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Malnutrition Assessed Through Bioelectrical Impedance Vector Analysis is Related to Poor Prognosis in Cirrhosis
Study Start Date : January 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : May 2014

Primary Outcome Measures :
  1. Hepatic encephalopathy [ Time Frame: 6, 12, 24, 36 and 48 months ]
    Assessed by west Haven criteria

Secondary Outcome Measures :
  1. Ascites [ Time Frame: 6, 12, 24, 36 and 48 months ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The participants will be recruited from the Gastroenterology Department of a tertiary care setting.

Inclusion Criteria:

  • Diagnose of cirrhosis.
  • Ambulatory patients

Exclusion Criteria:

  • Personal history of surgery in the last four weeks
  • Thyroid disorders without replacement therapy
  • Pregnancy
  • Active alcoholism with alcohol ingest in the previous 6 months.
  • Acute or chronic renal failure
  • Hepatic or renal transplant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01603953

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico, 14000
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study Chair: Aldo Torre Delgadillo, M.D. M.Sc INCMNSZ
Principal Investigator: Astrid Ruiz-Margáin, B.Sci Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Responsible Party: ALDO TORRE DELGADILLO, M.D. M.Sc, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Identifier: NCT01603953     History of Changes
Other Study ID Numbers: Gas-549-09-12-1
First Posted: May 23, 2012    Key Record Dates
Last Update Posted: November 18, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Liver Cirrhosis
Brain Diseases
Hepatic Encephalopathy
Pathologic Processes
Liver Diseases
Digestive System Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases