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NCT02926261 Clinical Trial

Methods for Nutritional Assessment in Cirrhosis

Malnutrition Clinical Trial

Official title:
Evaluation of Three Methods for Nutritional Assessment in Patients With Cirrhosis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02926261
Other study ID # BIVA0978
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 2016
Est. completion date December 2021

Study information
Verified date January 2020
Source Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Contact Aldo Torre, MD, MSc
Phone 5554870900
Email detoal@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Nutritional status in patients with cirrhosis has been shown to have a direct influence on the prognosis of these patients, it is related to higher mortality and it has been linked to the developement and perpetuation of certain complications such as hepatic encephalopathy, ascites and spontaneous bacterial peritonitis.

Despite the importance of nutritional status in this patients, most of the methods for its assessment are still not completely reliable or not easily accessible; therefore, evaluating nutritional status in the daily clinical practice is still a complex task.

Recruitment information / eligibility
Status Recruiting
Enrollment 180
Est. completion date December 2021
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Diagnosis of cirrhosis

- No restriction of etiology

- 18-75 years

- Child-Pugh stage A/B/C

- Signed informed consent

Exclusion Criteria:

- Pregnancy

- Extremity amputation

- Malignancy different from hepatocellular carcinoma

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Bioelectrical impedance vector analysis
Evaluation of nutritional status with Bioelectrical impedance vector analysis, hand-grip strength and computed-tomography scan

Locations
Country Name City State
Mexico Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán" Mexico City DF

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 Nutritional status Characterization of nutritional status by three methods of nutritional assessment
Bioelectrical impedance vector analysis
CT scan
Handgrip strength		 Evaluation at time of recruitment
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