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NCT02017301 Clinical Trial

Vector Analysis of Body Composition in Hospitalized Cirrhotic Patients

Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02017301
Other study ID # GAS-800-12-13-1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2012
Est. completion date April 2021

Study information
Verified date January 2019
Source Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Contact Aldo Torre Delgadillo, M.D. M.Sc
Phone 54870900
Email detoal@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 79
Est. completion date April 2021
Est. primary completion date April 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Nutritional assessment
Daily nutritional assessment with bioelectrical impedance vector analysis, phase angle and mid-arm muscle circumference

Locations
Country Name City State
Mexico Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubiran Mexico D.F

Sponsors (1)
Lead Sponsor Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in nutritional status Nutritional status will be measured with bioelectrical impedance analysis (Vector and phase angle) Daily measurement up to 30 days
Secondary Evaluation of inflammatory cytokines ELISA's test Samples will be collected at the baseline evaluation.
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