Bioelectrical Impedance Vector Analysis in Cirrhotic Patients

Completed

• Conditions: Hepatic Encephalopathy; Cirrhosis

• Registration Number: NCT01603953
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2012-05-20
• Study First Submitted QC: 2012-05-22
• Study First Posted: 2012-05-23
• Primary Completion: 2013-12
• Study Completion: 2014-05
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hepatic encephalopathy	6, 12, 24, 36 and 48 months	Assessed by west Haven criteria

Secondary Outcome Measures

Name	Time	Method
Ascites	6, 12, 24, 36 and 48 months

Trial Locations

Locations (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán; 🇲🇽 Mexico City, Mexico