Nutritional Therapy on Underweight Critically Ill Patients: an Observational Study

NCT ID: NCT03398343

Last Updated: 2018-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Underweight Critical Illness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mirela Jobim de Azevedo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

HCPA, Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mirela J Azevedo, Professor

Role: CONTACT

555133598127

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mirela J Azevedo, PhD

Role: primary

55(51)33598127

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 37202039 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31003789 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CAAE 45677715.2.0000.5327

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Refeeding Syndrome in Cancer Patients
NCT02534181 WITHDRAWN PHASE2