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NCT02022150 Clinical Trial

Body Composition Analysis in Cirrhotic Undergoing Paracentesis

Liver Cirrhosis Clinical Trial

— Paracentesis  

Official title:
Body Composition Analysis in Cirrhotic Patients With Ascites Undergoing Paracentesis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02022150
Other study ID # GAS-819-12/13-1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 2012
Est. completion date December 2021

Study information
Verified date January 2019
Source Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Contact Aldo Torre, M.D. M.Sci
Phone 54870900
Email detoal@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 2021
Est. primary completion date June 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Body composition in paracentesis
Takin blood samples and bioelectrical impedance measurmeent, Neuropsychological tests evaluation

Locations
Country Name City State
Mexico Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán" Mexico city D.F
Mexico Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán" Mexico city

Sponsors (1)
Lead Sponsor Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Body composition bioelectrical impedance vector analysis Baseline and 8 days post treatment
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