Body Composition Analysis in Cirrhotic Undergoing Paracentesis (Paracentesis)

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

Body Composition Analysis in Cirrhotic Patients With Ascites Undergoing Paracentesis

Ascites is a frequent complication of liver cirrhosis, initial treatment consists on diuretics intake, however, as the disease progresses this complication becomes more severe, consequently other therapeutic options are used.

Paracentesis is indicated when severe ascites is present and it should be accompanied by albumin infusion.

Nutritional status is generally affected in patients with liver cirrhosis, even more patients with severe ascites show decreased energy intake due to gastric compression.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

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
      • Mexico city, Mexico
        • Recruiting
        • Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
        • Principal Investigator:
          • Aldo Torre, M.D, M.Sc.
    • D.F
      • Mexico city, D.F, Mexico, 14000
        • Recruiting
        • Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
        • Contact:
        • Principal Investigator:
          • Aldo Torre, M.D, M.Sc.

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The cohort will be selected from the Liver Clinic, Department of Gastroenterology at a tertiary care center in Mexico

Description

Inclusion Criteria:

  • Any genre.
  • Age 18-70 years old.
  • Diagnosis of liver cirrhosis of any etiology (documented by clinical, biochemical, radiological and / or biopsy.
  • Presence of high volume ascites
  • The signing of informed consent will be required for the inclusion of any patient.

Exclusion Criteria:

  • Hepatic encephalopathy grade III or IV. 2) liver transplantation.
  • Congestive heart failure.
  • Hemodialysis.
  • Acute or chronic renal failure.
  • Nephrotic syndrome with protein loss.
  • Alcoholism active in the last 6 months.
  • Pregnancy.
  • upper gastrointestinal bleeding.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Body composition in paracentesis
Taking blood samples and bioelectrical impedance, Psychometric Hepatic Encephalopathy Score (PHES) and Critical Flicker Frequency (CFF) before and after paracentesis.
Behavioral: Body composition in paracentesis
Takin blood samples and bioelectrical impedance measurmeent, Neuropsychological tests evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: Baseline and 8 days post treatment
bioelectrical impedance vector analysis
Baseline and 8 days post treatment

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, M.D, M.Sc., Instituto Nacional de Nutrición y Ciencias Médicas "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

December 1, 2012

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

January 17, 2013

First Submitted That Met QC Criteria

December 20, 2013

First Posted (Estimate)

December 27, 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-819-12/13-1

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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