Validation of BIVA for Nutritional Assessment in Cirrhotic Patients

October 7, 2016 updated by: ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Mexico
- - Mexico city, Mexico, 14000
    - Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in nutritional status Time Frame: At the time of inclusion, every six months up to 36 months	It will be assessed by bioelectrical impedance vector analysis	At the time of inclusion, every six months up to 36 months

Other Outcome Measures

Outcome Measure	Time Frame
Evaluation of mortality Time Frame: Through study completion, an average of 36 months.	Through study completion, an average of 36 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Investigators

Study Chair: Aldo Torre, MD, MSc, Instituto Nacional de Nutrición y Ciencias Médicas "Salvador Zubirán"
Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

May 24, 2013

First Submitted That Met QC Criteria

June 6, 2013

First Posted (Estimate)

June 7, 2013

Study Record Updates

Last Update Posted (Estimate)

October 10, 2016

Last Update Submitted That Met QC Criteria

October 7, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

BIVA02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.