Validation of BIVA for Nutritional Assessment in Cirrhotic Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01872793

Enrollment

250

Registered

2013-06-07

Start date

2010-01-31

Completion date

2016-09-30

Last updated

2016-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis, Malnutrition

Keywords

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

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Other

Measure	Time frame
Evaluation of mortality	Through study completion, an average of 36 months.

Countries

Mexico

Outcome results