- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03398343
Nutritional Therapy on Underweight Critically Ill Patients: an Observational Study
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mirela J Azevedo, Professor
- Phone Number: 555133598127
- Email: mirelajobimazevedo@gmail.com
Study Locations
-
-
Rio Grande Do Sul
-
Porto Alegre, Rio Grande Do Sul, Brazil, 90035903
- Recruiting
- HCPA, Hospital de Clinicas de Porto Alegre
-
Contact:
- Mirela J Azevedo, PhD
- Phone Number: 55(51)33598127
- Email: mirelajobimazevedo@gmail.com
-
Sub-Investigator:
- Marina V Viana, MD
-
Principal Investigator:
- Mirela j Azevedo, PhD
-
Sub-Investigator:
- Luciana V Viana, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Ages eligible for study: 18 years and older
- Gender eligible: both
- Nutrition therapy: enteral, parenteral feeding, nothing by mouth
Exclusion Criteria:
- Palliative care
- Exclusively oral nutrition
- Pregnancy
- Life expectancy inferior 24 hours
- ICU readmission
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: through study completion (up to a year)
|
All patients will be followed until live hospital discharge or death
|
through study completion (up to a year)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ICU length of stay
Time Frame: through study completion (up to a year)
|
patients will be followed until ICU discharge or death
|
through study completion (up to a year)
|
Need and duration of mechanical ventilation
Time Frame: through study completion (up to a year)
|
all patients for which mechanical ventilation is necessary will be followed until it is no longer necessary
|
through study completion (up to a year)
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAE 45677715.2.0000.5327
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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