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Clinical Trials/NCT03398343
NCT03398343
Unknown
Not Applicable

Nutritional Therapy on Underweight Critically Ill Patients: an Observational Study

Hospital de Clinicas de Porto Alegre1 site in 1 country450 target enrollmentOctober 2015
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ConditionsUnderweightCritical Illness

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Underweight
Sponsor
Hospital de Clinicas de Porto Alegre
Enrollment
450
Locations
1
Primary Endpoint
Mortality
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
December 2018
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mirela Jobim de Azevedo

Professor

Hospital de Clinicas de Porto Alegre

Eligibility Criteria

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

Outcomes

Primary Outcomes

Mortality

Time Frame: through study completion (up to a year)

All patients will be followed until live hospital discharge or death

Secondary Outcomes

  • ICU length of stay(through study completion (up to a year))
  • Need and duration of mechanical ventilation(through study completion (up to a year))

Study Sites (1)

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