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Optimizing Protein Intake and Nitrogen Balance in Adult Critically Ill Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02990065
Acronym
OPINiB
Enrollment
40
Registered
2016-12-12
Start date
2017-01-01
Completion date
2018-09-30
Last updated
2021-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Protein Deficiency

Keywords

PROTEIN SUPPLEMENTATION, NUTRITIONAL STATUS

Brief 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.

Interventions

DIETARY_SUPPLEMENTPROTEIN SUPPLEMENTATION

Sponsors

University of Padova
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
nitrogen balance (gr)change from baseline through study completion, an average of 15 days(gr)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026