Clinical trial NCT02023177: Phase Angle and Mortality in Patients With Cirrhosis
Official title: Phase Angle as a Nutritional Marker Related to Prognosis Inpatients With Cirrhosis: A Cutt-off Value for Mexican Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Keywords: phase angle
liver cirrhosis
mortality
malnutrition
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2013-12-30
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population will be selected from the Liver Clinic at the Department of Gastroenterology in a tertiary care center in Mexico

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Nutritional status
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
measure: Nutritional status
timeFrame: 9 months
measure: Nutritional status
timeFrame: 18 months
measure: Nutritional status
timeFrame: 24 months
Locations:
city: Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
state: DF
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Aldo Torre, MD MSci
role: STUDY_DIRECTOR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Astrid Ruiz-Margáin, B.Sci
role: PRINCIPAL_INVESTIGATOR
References: