Body Composition Analysis in Cirrhotic Undergoing Paracentesis

• Conditions: Ascites; Liver Cirrhosis
• Interventions: Behavioral: Body composition in paracentesis

• Registration Number: NCT02022150
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-01-17
• Study First Submitted QC: 2013-12-20
• Study First Posted: 2013-12-27
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-02-01
• Primary Completion: 2021-06
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Body composition in paracentesis	Body composition in paracentesis	Taking blood samples and bioelectrical impedance, Psychometric Hepatic Encephalopathy Score (PHES) and Critical Flicker Frequency (CFF) before and after paracentesis.

Primary Outcome Measures

Name	Time	Method
Body composition	Baseline and 8 days post treatment	bioelectrical impedance vector analysis

Trial Locations

Locations (1)

Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"; 🇲🇽 Mexico city, Mexico