Nutritional Therapy on Underweight Critically Ill Patients: an Observational Study
1 other identifier
observational
450
1 country
1
Brief Summary
Critically ill patients with body mass index (BMI) inferior to 20 kg/m2 have worse outcomes compared to normal and overweight patients. The impact nutrition therapy in this population is not yet stablished. There is a concern that too low caloric intake might worse their malnutrition; on the other hand, overfeeding is always a risk with serious consequences. The hypothesis of this study is that nutritional support, especially caloric and protein intake, can influence the outcome of underweight critically ill patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2015
Typical duration 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
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 15, 2016
CompletedFirst Posted
Study publicly available on registry
January 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJanuary 12, 2018
February 1, 2017
2.4 years
March 15, 2016
January 7, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Mortality
All patients will be followed until live hospital discharge or death
through study completion (up to a year)
Secondary Outcomes (2)
ICU length of stay
through study completion (up to a year)
Need and duration of mechanical ventilation
through study completion (up to a year)
Eligibility Criteria
Critically ill patients with body mass index (BMI) inferior to 20 kg/m2
You may qualify if:
- Ages eligible for study: 18 years and older
- Gender eligible: both
- Nutrition therapy: enteral, parenteral feeding, nothing by mouth
You may not qualify if:
- Palliative care
- Exclusively oral nutrition
- Pregnancy
- Life expectancy inferior 24 hours
- ICU readmission
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
HCPA, Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035903, Brazil
Related Publications (2)
Viana MV, Gross LA, Tavares AL, Tonietto TA, Costa VL, Moraes RB, Azevedo MJ, Viana LV. Functional assessment and mortality in underweight critically ill patients one year after hospital discharge: A prospective cohort study. Clin Nutr ESPEN. 2023 Jun;55:151-156. doi: 10.1016/j.clnesp.2023.03.007. Epub 2023 Mar 15.
PMID: 37202039DERIVEDViana MV, Tavares AL, Gross LA, Tonietto TA, Costa VL, Moraes RB, Azevedo MJ, Viana LV. Nutritional therapy and outcomes in underweight critically ill patients. Clin Nutr. 2020 Mar;39(3):935-941. doi: 10.1016/j.clnu.2019.03.038. Epub 2019 Apr 5.
PMID: 31003789DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 15, 2016
First Posted
January 12, 2018
Study Start
October 1, 2015
Primary Completion
March 1, 2018
Study Completion
December 1, 2018
Last Updated
January 12, 2018
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share