Bioelectrical Impedance Vector Analysis in Cirrhotic Patients (BIVA)

Malnutrition Assessed Through Bioelectrical Impedance Vector Analysis is Related to Poor Prognosis in Cirrhosis

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

Study Overview

• Status: Completed
• Conditions: Hepatic Encephalopathy; Cirrhosis

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 14000
    • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The participants will be recruited from the Gastroenterology Department of a tertiary care setting.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hepatic encephalopathy	Assessed by west Haven criteria	6, 12, 24, 36 and 48 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Ascites	6, 12, 24, 36 and 48 months

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: May 20, 2012
• First Submitted That Met QC Criteria: May 22, 2012
• First Posted (Estimate): May 23, 2012

Study Record Updates

• Last Update Posted (Estimate): November 18, 2014
• Last Update Submitted That Met QC Criteria: November 17, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Liver Diseases; Brain Diseases, Metabolic; Fibrosis; Liver Cirrhosis; Hepatic Encephalopathy; Brain Diseases
• Other Study ID Numbers: Gas-549-09-12-1