Body Composition Analysis in Cirrhotic Undergoing Paracentesis

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Other)

Overall Status

Unknown status

CT.gov ID

NCT02022150

Collaborator

(none)

Enrollment

Locations

108

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhosis Ascites	Behavioral: Body composition in paracentesis

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Body Composition Analysis in Cirrhotic Patients With Ascites Undergoing Paracentesis

Study Start Date :

Dec 1, 2012

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Body composition [Baseline and 8 days post treatment]
bioelectrical impedance vector analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"	Mexico city	D.F	Mexico	14000
2	Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"	Mexico city		Mexico