Bioelectrical Impedance Vector Analysis in Cirrhotic Patients

Cirrhosis Clinical Trial

— BIVA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01603953
• Other study ID #: Gas-549-09-12-1
• Status: Completed
• Phase: N/A
• First received: May 20, 2012
• Last updated: November 17, 2014
• Start date: January 2009
• Est. completion date: May 2014

Study information

• Verified date: November 2014
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Diseases
• Cirrhosis
• Hepatic Encephalopathy
• Liver Cirrhosis

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic encephalopathy	Assessed by west Haven criteria	6, 12, 24, 36 and 48 months	No
Secondary	Ascites		6, 12, 24, 36 and 48 months	No