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Bioelectrical Impedance Vector Analysis in Cirrhotic Patients (BIVA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT01603953
First received: May 20, 2012
Last updated: November 17, 2014
Last verified: November 2014
  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 Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:

Primary Outcome Measures:
  • Hepatic encephalopathy [ Time Frame: 6, 12, 24, 36 and 48 months ] [ Designated as safety issue: No ]
    Assessed by west Haven criteria


Secondary Outcome Measures:
  • Ascites [ Time Frame: 6, 12, 24, 36 and 48 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 20, 2012
Last Updated: November 17, 2014
Health Authority: Mexico: Secretaria de Salud

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

ClinicalTrials.gov processed this record on November 24, 2014