Validation of BIVA for Nutritional Assessment in Cirrhotic Patients

NCT01872793 | Completed

• 1 other identifier: BIVA02
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Liver Cirrhosis; Malnutrition

Keywords

bioelectrical impedance vector analysis; nutritional assessment; nutritional status; mortality; complications

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• Evaluation of mortality

  Through study completion, an average of 36 months.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants will be recruited from the Gastroenterology Department of a tertiary care setting.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"

Mexico City, 14000, Mexico

Location

MeSH Terms

Conditions

Liver Cirrhosis; Malnutrition

Condition Hierarchy (Ancestors)

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

Study Officials

• Aldo Torre, MD, MSc

  Instituto Nacional de Nutrición y Ciencias Médicas "Salvador Zubirán"

  STUDY CHAIR

• Astrid Ruiz-Margain, BSc, MSc

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

• Ricardo Macías-Rodriguez, MD, MSc

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., M.Sc.

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: June 7, 2013
• Study Start: January 1, 2010
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 10, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)