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

University of Padova

Status: Completed

Conditions: Protein Deficiency

Treatments: Dietary Supplement: PROTEIN SUPPLEMENTATION

Study type: Interventional

Funder types: Other

Identifiers

NCT02990065

OPINiB 2016

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

PROTEIN-FORTIFIED DIET

Experimental group

Description:

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).

Treatment:

Dietary Supplement: PROTEIN SUPPLEMENTATION

STANDARD DIET

No Intervention group

Description:

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).