Validation of BIVA for Nutritional Assessment in Cirrhotic Patients

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872793
• Other study ID #: BIVA02
• Status: Completed
• Phase: N/A
• First received: May 24, 2013
• Last updated: October 7, 2016
• Start date: January 2010
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Malnutrition

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"	Mexico city

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	Evaluation of mortality		Through study completion, an average of 36 months.	No
Primary	Changes in nutritional status	It will be assessed by bioelectrical impedance vector analysis	At the time of inclusion, every six months up to 36 months	No