Nutritional Therapy on Underweight Critically Ill Patients: an Observational Study

Critical Illness Clinical Trial

Official title:

Nutritional Therapy on Underweight Critically Ill Patients: an Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03398343
• Other study ID #: CAAE 45677715.2.0000.5327
• Status: Recruiting
• Phase: N/A
• First received: March 15, 2016
• Last updated: January 7, 2018
• Start date: October 2015
• Est. completion date: December 2018

Study information

• Verified date: February 2017
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Mirela J Azevedo, Professor
• Phone: 555133598127
• Email: mirelajobimazevedo[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Thinness
• Underweight

Locations

Country	Name	City	State
Brazil	HCPA, Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	All patients will be followed until live hospital discharge or death	through study completion (up to a year)
Secondary	ICU length of stay	patients will be followed until ICU discharge or death	through study completion (up to a year)
Secondary	Need and duration of mechanical ventilation	all patients for which mechanical ventilation is necessary will be followed until it is no longer necessary	through study completion (up to a year)