Optimizing Protein Intake and Nitrogen Balance in Adult Critically Ill Patients

The purposes of the study are:

* To strictly ensure the appropriate level of protein and caloric provision in critical illness, according to the latest literature recommendation; * To determine if an association exists between protein intake and nitrogen balance in the context of a nutrition with appropriate protein provision based on the latest literature recommendations, rather than in a standard diet with a caloric target weight-based. Creatinine clearance will also be evaluated to determine if there is any harmful effect to the kidney secondary to an elevated BUN. * To determine if there is a difference in ICU mortality rate between the current nutrition standard and a hyperproteic nutrition protocol.

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Key information

Conditions

Protein Deficiency Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age > 18 years
Receiving PN and/or EN nutrition
Indwelling urinary catheter
Mechanically ventilated patients

Exclusion criteria

Age < 18 years
Chronic renal or hepatic failure
Current or history (past 6 months) of GI bleeding
BMI >30 kg/m2 o <18 kg/m2
Terminally ill patients
Pregnancy

Treatment and study plan

Protein supplementation

Dietary Supplement

Primary outcomes

nitrogen balance (gr)

Time frame: change from baseline through study completion, an average of 15 days

(gr)

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

Optimizing Protein Intake and Nitrogen Balance in Adult Critically Ill Patients: a Randomized Controlled Trial (OPINiB STUDY)

Acronym: OPINiB

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Dec 12, 2016
Registry last updated: Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed