Optimizing Protein Intake and Nitrogen Balance in Adult Critically Ill Patients (OPINiB)
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|ClinicalTrials.gov Identifier: NCT02990065|
Recruitment Status : Unknown
Verified December 2016 by Dario Gregori, University of Padova.
Recruitment status was: Not yet recruiting
First Posted : December 12, 2016
Last Update Posted : December 12, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Protein Deficiency||Dietary Supplement: PROTEIN SUPPLEMENTATION||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Optimizing Protein Intake and Nitrogen Balance in Adult Critically Ill Patients: a Randomized Controlled Trial (OPINiB STUDY)|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||June 2017|
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).
- nitrogen balance (gr) [ Time Frame: change from baseline through study completion, an average of 15 days ](gr)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990065
|Contact: Mariangela Ruffolo, MSemail@example.com|