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Methods for Nutritional Assessment in Cirrhosis

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ClinicalTrials.gov Identifier: NCT02926261
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief 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.


Condition or disease Intervention/treatment
Liver Cirrhosis Cachexia Malnutrition Other: Bioelectrical impedance vector analysis

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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Evaluation of Three Methods for Nutritional Assessment in Patients With Cirrhosis
Actual Study Start Date : December 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis


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


Primary Outcome Measures :
  1. Nutritional status [ Time Frame: Evaluation at time of recruitment ]

    Characterization of nutritional status by three methods of nutritional assessment

    • Bioelectrical impedance vector analysis
    • CT scan
    • Handgrip strength


Biospecimen Retention:   Samples Without DNA
Serum and plasma samples collected at time of evaluation and stored at -80°.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cohort of patients with cirrhosis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926261


Contacts
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Contact: Aldo Torre, MD, MSc 5554870900 ext 2711 detoal@yahoo.com

Locations
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Mexico
Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán" Recruiting
Mexico City, DF, Mexico, 14080
Contact: Aldo Torre Delgadillo, BSc, MSc       detoal@yahoo.mx   
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
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Principal Investigator: Aldo Torre, MD, MSc Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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Responsible Party: ALDO TORRE DELGADILLO, MD, MSc, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT02926261     History of Changes
Other Study ID Numbers: BIVA0978
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Malnutrition
Fibrosis
Cachexia
Pathologic Processes
Liver Diseases
Digestive System Diseases
Nutrition Disorders
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms