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Clinical Trials/NCT01872793
NCT01872793
Completed
Not Applicable

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

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran1 site in 1 country250 target enrollmentJanuary 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Liver Cirrhosis
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Enrollment
250
Locations
1
Primary Endpoint
Changes in nutritional status
Status
Completed
Last Updated
9 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
September 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Responsible Party
Principal Investigator
Principal Investigator

ALDO TORRE DELGADILLO

M.D., M.Sc.

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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