Vector Analysis of Body Composition in Hospitalized Cirrhotic Patients

NCT02017301 | Unknown

• 1 other identifier: GAS-800-12-13-1
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infection

Keywords

Liver Cirrhosis,Infection, Impedance, Body Composition

Outcome Measures

Primary Outcomes (1)

• Changes in nutritional status

  Nutritional status will be measured with bioelectrical impedance analysis (Vector and phase angle)

  Daily measurement up to 30 days

Secondary Outcomes (1)

• Evaluation of inflammatory cytokines

  Samples will be collected at the baseline evaluation.

Interventions

Nutritional assessment OTHER

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cohort of hospitalized cirrhotic patients

You may qualify if:

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

You may not qualify if:

• Pregnancy
• Amputation
• Incomplete data

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubiran

México, D.F, 14080, Mexico

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma samples

MeSH Terms

Conditions

Infections; Liver Cirrhosis

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Aldo Torre Delgadillo, M.D. M.Sc

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

• Astrid Ruiz-Margáin, M.Sc

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aldo Torre Delgadillo, M.D. M.Sc

CONTACT

54870900; detoal@yahoo.com

Astrid Ruiz-Margáin, M.Sc

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigador Oficial

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 20, 2013
• Study Start: November 1, 2012
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2021
• Last Updated: February 1, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)