Body Composition Analysis in Cirrhotic Undergoing Paracentesis

NCT ID: NCT02022150

Last Updated: 2019-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2021-12-31

Brief Summary

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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

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Conditions

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Liver Cirrhosis Ascites

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Body composition in paracentesis

Taking blood samples and bioelectrical impedance, Psychometric Hepatic Encephalopathy Score (PHES) and Critical Flicker Frequency (CFF) before and after paracentesis.

Body composition in paracentesis

Intervention Type BEHAVIORAL

Takin blood samples and bioelectrical impedance measurmeent, Neuropsychological tests evaluation

Interventions

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Body composition in paracentesis

Takin blood samples and bioelectrical impedance measurmeent, Neuropsychological tests evaluation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role lead

Responsible Party

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ALDO TORRE DELGADILLO

M.D. M.Sc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aldo Torre, M.D, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Nutrición y Ciencias Médicas "Salvador Zubirán"

Locations

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Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"

Mexico City, D.F, Mexico

Site Status RECRUITING

Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"

Mexico City, , Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Aldo Torre, M.D. M.Sci

Role: CONTACT

54870900 ext. 2709

Facility Contacts

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Aldo Torre, M.D., M.Sc.

Role: primary

54870900 ext. 2711

Other Identifiers

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GAS-819-12/13-1

Identifier Type: -

Identifier Source: org_study_id

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