Nutritional Therapy on Underweight Critically Ill Patients: an Observational Study

January 7, 2018 updated by: Mirela Jobim de Azevedo, Hospital de Clinicas de Porto Alegre

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

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035903
        • Recruiting
        • HCPA, Hospital de Clinicas de Porto Alegre
        • Contact:
        • Sub-Investigator:
          • Marina V Viana, MD
        • Principal Investigator:
          • Mirela j Azevedo, PhD
        • Sub-Investigator:
          • Luciana V Viana, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ANTICIPATED)

March 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

March 15, 2016

First Submitted That Met QC Criteria

January 7, 2018

First Posted (ACTUAL)

January 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 12, 2018

Last Update Submitted That Met QC Criteria

January 7, 2018

Last Verified

February 1, 2017

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)?

NO

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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