Optimizing Protein Intake and Nitrogen Balance in Adult Critically Ill Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Protein Deficiency

Intervention / Treatment
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* Dietary Supplement: PROTEIN SUPPLEMENTATION


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PROTEIN-FORTIFIED DIET<br>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<br> <br> |
| No Intervention: STANDARD DIET<br>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?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PROTEIN SUPPLEMENTATION, NUTRITIONAL STATUS