Vector Analysis of Body Composition in Hospitalized Cirrhotic Patients

January 30, 2019 updated by: ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Influence of Acute Decompensation on Body Composition Determined by Bioelectrical Impedance Vector Analysis

Patients with acute decompensation of cirrhosis, or acute on chronic liver failure often present with malnutrition, and due to the in-hospital stay, their nutritional intake can vary widely, with several periods of fasting, and sometimes insufficient nutritional support. Therefore patients are prone to develop malnutrition or, the already present malnutrition worsens its status.

Our aim is to evaluate the daily changes in nutritional status in patients with acute decompensation of cirrhosis and evaluate the changes in plasma and serum biomarkers.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

79

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • D.F
      • Mexico, D.F, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
        • Contact:
          • Aldo
        • Principal Investigator:
          • Aldo Torre Delgadillo, M.D. M.S.ci

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cohort of hospitalized cirrhotic patients

Description

Inclusion Criteria:

  • Age 18-75 years old
  • Patients with confirmed cirrhosis.
  • Any etiology
  • Hospitalized with acute decompensation of cirrhosis
  • Signed informed consent

Exclusion Criteria:

  • Pregnancy
  • Amputation
  • Incomplete data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in nutritional status
Time Frame: Daily measurement up to 30 days
Nutritional status will be measured with bioelectrical impedance analysis (Vector and phase angle)
Daily measurement up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of inflammatory cytokines
Time Frame: Samples will be collected at the baseline evaluation.
ELISA's test
Samples will be collected at the baseline evaluation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Investigators

  • Principal Investigator: Aldo Torre Delgadillo, M.D. M.Sc, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
  • Principal Investigator: Astrid Ruiz-Margáin, M.Sc, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2012

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

December 6, 2012

First Submitted That Met QC Criteria

December 16, 2013

First Posted (Estimate)

December 20, 2013

Study Record Updates

Last Update Posted (Actual)

February 1, 2019

Last Update Submitted That Met QC Criteria

January 30, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAS-800-12-13-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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