Body Composition Analysis in Cirrhotic Undergoing Paracentesis
Paracentesis
1 other identifier
observational
20
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2012
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 17, 2013
CompletedFirst Posted
Study publicly available on registry
December 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedFebruary 1, 2019
January 1, 2019
8.5 years
January 17, 2013
January 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Body composition
bioelectrical impedance vector analysis
Baseline and 8 days post treatment
Study Arms (1)
Body composition in paracentesis
Taking blood samples and bioelectrical impedance, Psychometric Hepatic Encephalopathy Score (PHES) and Critical Flicker Frequency (CFF) before and after paracentesis.
Interventions
Takin blood samples and bioelectrical impedance measurmeent, Neuropsychological tests evaluation
Eligibility Criteria
The cohort will be selected from the Liver Clinic, Department of Gastroenterology at a tertiary care center in Mexico
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
Mexico City, D.F, 14000, Mexico
Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
Mexico City, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aldo Torre, M.D, M.Sc.
Instituto Nacional de Nutrición y Ciencias Médicas "Salvador Zubirán"
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D. M.Sc
Study Record Dates
First Submitted
January 17, 2013
First Posted
December 27, 2013
Study Start
December 1, 2012
Primary Completion
June 1, 2021
Study Completion
December 1, 2021
Last Updated
February 1, 2019
Record last verified: 2019-01