UnderweightNCT03398343
Nutritional Therapy on Underweight Critically Ill Patients: an Observational Study
An observational study of Underweight and Critical Illness, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Underweight, Critical Illness
- How many people
- 450 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2015to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients with body mass index (BMI) inferior to 20 kg/m2
Who may be able to join
- Ages eligible for study: 18 years and older
- Gender eligible: both
- Nutrition therapy: enteral, parenteral feeding, nothing by mouth
Who cannot join
- Palliative care
- Exclusively oral nutrition
- Pregnancy
- Life expectancy inferior 24 hours
- ICU readmission
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
HCPA, Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035903
Mirela J Azevedo, PhD, 55(51)33598127, mirelajobimazevedo@gmail.com
Marina V Viana, MD
About this 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.
- Conditions
- Underweight, Critical Illness
- Medical subject headings
- Thinness, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
All patients will be followed until live hospital discharge or death
Measured: through study completion (up to a year)
Secondary outcomes (2)
ICU length of stay
patients will be followed until ICU discharge or death
Measured: through study completion (up to a year)
Need and duration of mechanical ventilation
all patients for which mechanical ventilation is necessary will be followed until it is no longer necessary
Measured: through study completion (up to a year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study startOct 2015
- Primary completionMar 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for UnderweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirela Jobim de Azevedo, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398343
- Sponsor's protocol ID
- CAAE 45677715.2.0000.5327
- Status last verified
- Feb 2017
- First submitted
- 15 Mar 2016
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37202039Viana 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Therapy on Underweight Critically Ill Patients: an Observational Study
- ClinicalTrials.gov ID
- NCT03398343
- Acronym / sponsor ID
- CAAE 45677715.2.0000.5327
- Conditions
- Underweight, Critical Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 12 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients with body mass index (BMI) inferior to 20 kg/m2
Key inclusion criteria (3 listed)
- Ages eligible for study: 18 years and older
- Gender eligible: both
- Nutrition therapy: enteral, parenteral feeding, nothing by mouth
Key exclusion criteria (5 listed)
- Palliative care
- Exclusively oral nutrition
- Pregnancy
- Life expectancy inferior 24 hours
- ICU readmission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: through study completion (up to a year)
All patients will be followed until live hospital discharge or death
2 secondary outcomes
ICU length of stay
Time frame: through study completion (up to a year)
Need and duration of mechanical ventilation
Time frame: through study completion (up to a year)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- Derived from this study: PubMed 37202039Viana 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.
- Derived from this study: PubMed 31003789Viana 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Underweight and Critical Illness, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mirela J Azevedo, Professor (555133598127, mirelajobimazevedo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: through study completion (up to a year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03398343, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2018.