Phase Angle and Mortality in Patients With Cirrhosis

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02023177
• Other study ID #: PhA01
• Status: Completed
• Phase: N/A
• First received: December 18, 2013
• Last updated: November 14, 2014
• Start date: January 2008
• Est. completion date: September 2013

Study information

• Verified date: November 2014
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: September 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Malnutrition

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Mexico	DF

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nutritional status	Phase angle obtained from bioelectrical impedance	9 months	No
Other	Nutritional status	Phase angle obtained from bioelectrical impedance	18 months	No
Other	Nutritional status	Phase angle obtained from bioelectrical impedance	24 months	No
Primary	Nutritional status	Phase angle obtained from bioelectrical impedance	Baseline	No