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Phase Angle and Mortality in Patients With Cirrhosis

NCT ID: NCT02023177

Last Updated: 2014-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

249 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Malnutrition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Phase angle

Phase angle obtained from bioelectrical impedance

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role lead

Responsible Party

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ALDO TORRE DELGADILLO

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aldo Torre, MD MSci

Role: STUDY_DIRECTOR

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Astrid Ruiz-Margáin, B.Sci

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Locations

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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico City, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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PhA01

Identifier Type: -

Identifier Source: org_study_id