Bioelectrical Impedance Vector Analysis in Cirrhotic Patients

NCT01603953 | Completed

• 1 other identifier: Gas-549-09-12-1
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cirrhosis; Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• Hepatic encephalopathy

  Assessed by west Haven criteria

  6, 12, 24, 36 and 48 months

Secondary Outcomes (1)

• Ascites

  6, 12, 24, 36 and 48 months

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Diagnose of cirrhosis.
• Ambulatory patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14000, Mexico

Location

MeSH Terms

Conditions

Fibrosis; Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Aldo Torre Delgadillo, M.D. M.Sc

  INCMNSZ

  STUDY CHAIR

• Astrid Ruiz-Margáin, B.Sci

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. M.Sc

Study Record Dates

• First Submitted: May 20, 2012
• First Posted: May 23, 2012
• Study Start: January 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: May 1, 2014
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

ME (1)