Optimizing Protein Intake and Nitrogen Balance in Adult Critically Ill Patients

Protein Deficiency Clinical Trial

— OPINiB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02990065
• Other study ID #: OPINiB 2016
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: April 2021
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Protein Deficiency

Intervention

Dietary Supplement:
• PROTEIN SUPPLEMENTATION

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nitrogen balance (gr)	(gr)	change from baseline through study completion, an average of 15 days