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Validation of BIVA for Nutritional Assessment in Cirrhotic Patients

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ClinicalTrials.gov Identifier: NCT01872793
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : October 10, 2016
Sponsor:
Information provided by (Responsible Party):
ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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


Condition or disease
Liver Cirrhosis Malnutrition

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Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Bioelectrical Impedance Vector Analysis for Nutritional Assessment in Patients With Cirrhosis
Study Start Date : January 2010
Actual Primary Completion Date : July 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis




Primary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Evaluation of mortality [ Time Frame: Through study completion, an average of 36 months. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The participants will be recruited from the Gastroenterology Department of a tertiary care setting.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872793


Locations
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Mexico
Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
Mexico city, Mexico, 14000
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
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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

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Responsible Party: ALDO TORRE DELGADILLO, M.D., M.Sc., Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT01872793     History of Changes
Other Study ID Numbers: BIVA02
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: October 10, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
bioelectrical impedance vector analysis
nutritional assessment
nutritional status
mortality
complications

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Malnutrition
Pathologic Processes
Liver Diseases
Digestive System Diseases
Nutrition Disorders