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Completed

NCT Number: NCT02023177

Phase Angle and Mortality in Patients With Cirrhosis

A few PhA cut-off points have been proposed to define malnutrition in cirrhosis, and they have proven to be useful in prognosticating severity of the disease and mortality. However, PhA needs specific validation in different ethnic groups. The aim of this study was to evaluate the PhA cut-off value that would best define malnutrition and predict mortality in patients with liver cirrhosis.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, 14000, Mexico

About this study

Malnutrition is a frequent complication of cirrhosis, and it has been associated with a more severe disease and decompensating events. Despite its relevance, there is no gold standard for nutritional assessment in cirrhosis, and intrinsic pathophysiologic changes make biochemical markers and traditional methods used to evaluate malnutrition unreliable. Phase angle (PhA) obtained from bioelectrical impedance has been successfully used as a nutritional marker in several diseases such as chronic renal failure, cancer, and HIV, where it has been associated with prolonged in-hospital stay and mortality. In cirrhosis, research linking malnutrition to increased mortality has yielded conflicting results, likely due to the lack of a gold standard. A few PhA cut-off points have been proposed to define malnutrition in cirrhosis, and they have proven to be useful in prognosticating severity of the disease and mortality. However, PhA needs specific validation in different ethnic groups. The aim of this study was to evaluate the PhA cut-off value that would best define malnutrition and predict mortality in patients with liver cirrhosis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-65 years old ambulatory patients Diagnosis of liver cirrhosis

Exclusion criteria

  • Acute or chronic liver failure heart failure hepatocellular carcinoma pregnancy acute infections

Treatment and study plan

Primary outcomes

  1. Nutritional status

    Time frame: Baseline

    Phase angle obtained from bioelectrical impedance

Other outcomes

  1. Nutritional status

    Time frame: 9 months

    Phase angle obtained from bioelectrical impedance

  2. Nutritional status

    Time frame: 18 months

    Phase angle obtained from bioelectrical impedance

  3. Nutritional status

    Time frame: 24 months

    Phase angle obtained from bioelectrical impedance

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Registry information

Official study title

Phase Angle as a Nutritional Marker Related to Prognosis Inpatients With Cirrhosis: A Cutt-off Value for Mexican Population

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Dec 30, 2013
Registry last updated
Nov 18, 2014

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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