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Status unknownNCT03398343Updated Jan 12, 2018

Nutritional Therapy on Underweight Critically Ill Patients: an Observational Study

An observational study in Underweight and Critical Illness, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-12.

Sponsored by Hospital de Clinicas de Porto Alegre · Observational

The sponsor has not verified this record recently (last verified Feb 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
450
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Underweight
  • Critical Illness
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Critically ill patients with body mass index (BMI) inferior to 20 kg/m2

Inclusion criteria

  • Ages eligible for study: 18 years and older
  • Gender eligible: both
  • Nutrition therapy: enteral, parenteral feeding, nothing by mouth

Exclusion criteria

Exclusion Criteria:

  • Palliative care
  • Exclusively oral nutrition
  • Pregnancy
  • Life expectancy inferior 24 hours
  • ICU readmission
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
450 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Mortality

    All patients will be followed until live hospital discharge or death

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

Secondary outcomes

  1. ICU length of stay

    patients will be followed until ICU discharge or death

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

  2. Need and duration of mechanical ventilation

    all patients for which mechanical ventilation is necessary will be followed until it is no longer necessary

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

06

Study locations

1 of 1 sites recruiting
  • HCPA, Hospital de Clinicas de Porto Alegre
    Porto Alegre, Rio Grande Do Sul 90035903, Brazil
    • Mirela J Azevedo, PhD · Contact · mirelajobimazevedo@gmail.com · 55(51)33598127
    • Marina V Viana, MD · Sub investigator
    • Mirela j Azevedo, PhD · Principal investigator
    • Luciana V Viana, PhD · Sub investigator
    Recruiting
07

References and documents

Publications

  • Viana 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. PubMed 31003789 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03398343
Lead sponsor
Hospital de Clinicas de Porto Alegre
Responsible party
Mirela Jobim de Azevedo (Professor, Hospital de Clinicas de Porto Alegre) — Principal investigator
First posted
Jan 12, 2018
Start date
Oct 2015
Primary completion
Mar 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Jan 12, 2018

Study contacts

Mirela J Azevedo, Professor
Contact
mirelajobimazevedo@gmail.com
555133598127

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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