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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: September 18, 2012
Last verified: September 2012
History of Changes
  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.

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 purpose of this study is to validate bioelectrical impedance vector analysis as a useful method for nutritional assessment in cirrhotic patients.


Condition
Liver Cirrhosis
Malnutrition

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Bioelectrical Impedance Vector Analysis is a Better Tool for Assessing Nutritional Status in Cirrhotic Patients

Resource links provided by NLM:

U.S. FDA Resources

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

Enrollment: 310
Study Start Date: January 2010
Study Completion Date: September 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 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 liver cirrhosis by two or more of the following criteria:
  • Albumin < 3.4 g/dL
  • INR ≥ 1.3
  • Total bilirubin ≥ 2 mg/dL
  • Portal hypertension (esophageal varices, splenomegaly, ascites, etc.)
  • Liver biopsy
  • 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
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
  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: September 18, 2012
Health Authority: Mexico: Secretaria de Salud

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Malnutrition
Liver Diseases
 Digestive System Diseases
Pathologic Processes
Nutrition Disorders

ClinicalTrials.gov processed this record on May 16, 2013