We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bioelectrical Impedance Vector Analysis in Cirrhotic Patients (BIVA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01603953
First Posted: May 23, 2012
Last Update Posted: November 18, 2014
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.
Information provided by (Responsible Party):
ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  Purpose

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
Cirrhosis Hepatic Encephalopathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Malnutrition Assessed Through Bioelectrical Impedance Vector Analysis is Related to Poor Prognosis in Cirrhosis

Resource links provided by NLM:


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

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


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

Enrollment: 250
Study Start Date: January 2009
Study Completion Date: May 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01603953


Locations
Mexico
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
Investigators
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
  More Information

Responsible Party: ALDO TORRE DELGADILLO, M.D. M.Sc, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT01603953     History of Changes
Other Study ID Numbers: Gas-549-09-12-1
First Submitted: May 20, 2012
First Posted: May 23, 2012
Last Update Posted: November 18, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Fibrosis
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