Validation of BIVA for Nutritional Assessment in Cirrhotic Patients

Completed

• Conditions: Malnutrition; Liver Cirrhosis

• Registration Number: NCT01872793
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief Summary

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.).

With previous results from our research group, BIVA showed to be useful for evaluating cirrhotic patients.

The aim of this study is to validate our previous results and validate BIVA for nutritional assessment in patients with liver cirrhosis

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2013-05-24
• Study First Submitted QC: 2013-06-06
• Study First Posted: 2013-06-07
• Primary Completion: 2016-07
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-07
• Last Update Posted: 2016-10-10

Recruitment & Eligibility

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in nutritional status	At the time of inclusion, every six months up to 36 months	It will be assessed by bioelectrical impedance vector analysis

Trial Locations

Locations (1)

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