Validation of BIVA for Nutritional Assessment in Cirrhotic Patients

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

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Key information

Conditions

Liver Cirrhosis Digestive System Diseases Fibrosis Liver Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"

Mexico City, 14000, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Changes in nutritional status

Time frame: At the time of inclusion, every six months up to 36 months

It will be assessed by bioelectrical impedance vector analysis

Other outcomes

Evaluation of mortality

Time frame: Through study completion, an average of 36 months.

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Registry information

Official study title

Validation of Bioelectrical Impedance Vector Analysis for Nutritional Assessment in Patients With Cirrhosis

Important dates

Study start: 2010
Primary completion: 2016
Study completion: 2016
First posted: Jun 7, 2013
Registry last updated: Oct 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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