Methods for Nutritional Assessment in Cirrhosis
Evaluation of Three Methods for Nutritional Assessment in Patients With Cirrhosis
1 other identifier
observational
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2016
CompletedFirst Posted
Study publicly available on registry
October 6, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedFebruary 28, 2020
January 1, 2020
4 years
October 5, 2016
February 27, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Interventions
Evaluation of nutritional status with Bioelectrical impedance vector analysis, hand-grip strength and computed-tomography scan
Eligibility Criteria
Cohort of patients with cirrhosis
You may qualify if:
- Diagnosis of cirrhosis
- No restriction of etiology
- years
- Child-Pugh stage A/B/C
- Signed informed consent
You may not qualify if:
- Pregnancy
- Extremity amputation
- Malignancy different from hepatocellular carcinoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
Mexico City, Mexico City, 14080, Mexico
Biospecimen
Serum and plasma samples collected at time of evaluation and stored at -80°.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aldo Torre, MD, MSc
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, MSc
Study Record Dates
First Submitted
October 5, 2016
First Posted
October 6, 2016
Study Start
December 1, 2016
Primary Completion
December 1, 2020
Study Completion
December 1, 2021
Last Updated
February 28, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share