Optimizing Protein Intake and Nitrogen Balance in Adult Critically Ill Patients (OPINiB)

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

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.

Study Overview

• Status: Completed
• Conditions: Protein Deficiency
• Intervention / Treatment: Dietary supplement: PROTEIN SUPPLEMENTATION

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PROTEIN-FORTIFIED DIET; The protein-fortified diet consists on an energy goal based on REE measurement and a protein target based on the most recent literature recommendations (1.2-2 g/kg/die) (2). Daily caloric requirement, and subsequent protein content, of patients enrolled in the intervention group will be calculated using formulas in Table 1 (10, 12, 13). For each patient will be calculated the Resting Energy Expenditure (REE) and daily protein requirement (1.2-2g/kg/die of body weight registered at the admission) and the corresponding caloric intake (1g = 4 kcal). Finally, total daily caloric intake will be calculated by adding kcal from protein (1g = 4kcal) on kcal from non-protein (50% of REE).	Dietary supplement: PROTEIN SUPPLEMENTATION
No Intervention: STANDARD DIET; The standard diet consists on an energy goal based on weight formula (20-25 kcal/kg/die). According to the ICU nutritional protocol, EN is started at an initial rate of 10ml/h, and increased by 20ml/h every 12 hours in the absence of significant gastric residuals (<250ml), with the aim of reaching the energy goal within 72 hours from admission. The EN formulae used are standard (1-1,5 kcal/ml, 40g/l protein). If enteral nutrition is not tolerated or is not indicated, supplemental PN is used to make up the energy shortfall. The PN formula used is standard (1000 kcal/l, 37 g/l protein).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nitrogen balance (gr)	(gr)	change from baseline through study completion, an average of 15 days

Collaborators and Investigators

• Sponsor: University of Padova

Publications and helpful links

General Publications

• Danielis M, Lorenzoni G, Cavaliere L, Ruffolo M, Peressoni L, De Monte A, Muzzi R, Beltrame F, Gregori D. Optimizing Protein Intake and Nitrogen Balance (OPINiB) in Adult Critically Ill Patients: A Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2017 May 9;6(5):e78. doi: 10.2196/resprot.7100.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: November 28, 2016
• First Submitted That Met QC Criteria: December 9, 2016
• First Posted (Estimate): December 12, 2016

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: PROTEIN SUPPLEMENTATION; NUTRITIONAL STATUS
• Additional Relevant MeSH Terms: Nutrition Disorders; Deficiency Diseases; Malnutrition; Protein Deficiency
• Other Study ID Numbers: OPINiB 2016