Validation of BIVA for Nutritional Assessment in Cirrhotic Patients

NCT ID: NCT01872793

Last Updated: 2016-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2016-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Liver Cirrhosis Malnutrition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role lead

Responsible Party

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ALDO TORRE DELGADILLO

M.D., M.Sc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aldo Torre, MD, MSc

Role: STUDY_CHAIR

Instituto Nacional de Nutrición y Ciencias Médicas "Salvador Zubirán"

Astrid Ruiz-Margain, BSc, MSc

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Ricardo Macías-Rodriguez, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Locations

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Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"

Mexico City, , Mexico

Site Status

Countries

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Mexico

Other Identifiers

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BIVA02

Identifier Type: -

Identifier Source: org_study_id

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