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CompletedNCT01872793Updated Oct 10, 2016

Validation of BIVA for Nutritional Assessment in Cirrhotic Patients

An observational study in Liver Cirrhosis and Malnutrition, sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. Completed at 1 site in Mexico. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-10-10.

Sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
18 Years to 70 Years
Sex
All
01

Study 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

02

Conditions studied

  • Liver Cirrhosis
  • Malnutrition

Keywords

  • bioelectrical impedance vector analysis
  • nutritional assessment
  • nutritional status
  • mortality
  • complications
03

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's enrollment of 250 is above the median of 151 across 587 observational studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran is the lead sponsor of 141 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Changes in nutritional status

    It will be assessed by bioelectrical impedance vector analysis

    Time frame: At the time of inclusion, every six months up to 36 months

Other outcomes

  1. Evaluation of mortality

    Time frame: Through study completion, an average of 36 months.

07

Study locations

1 site
  • Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
    Mexico city, 14000, Mexico
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01872793
Lead sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Responsible party
ALDO TORRE DELGADILLO (M.D., M.Sc., Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran) — Principal investigator
First posted
Jun 7, 2013
Start date
Jan 2010
Primary completion
Jul 2016
Completion
Sep 2016
Last update
Oct 10, 2016

Study contacts

Aldo Torre, MD, MSc
study chair · Instituto Nacional de Nutrición y Ciencias Médicas "Salvador Zubirán"
Astrid Ruiz-Margain, BSc, MSc
principal investigator · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Ricardo Macías-Rodriguez, MD, MSc
principal investigator · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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