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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Controlled enteral nutrition in critical care patients - A randomized clinical trial of a novel management system
Ilya Kagan1, Moran Hellerman-Itzhaki1, Itai Bendavid1
1Department of General Intensive Care and Institute for Nutrition Research, Rabin Medical Center, Beilinson Hospital, University of Tel Aviv, Petah TIkva 49100, Israel.
Purpose:
Nutritional therapy is essential to ICU care. Successful early enteral feeding is hindered by lack of protocols, gastrointestinal intolerance and feeding interruptions, leading to impaired nutritional intake. smART+ was developed as a nutrition management feeding platform controlling tube positioning, reflux, gastric pressure, and malnutrition. This study evaluated the potential of this new ICU care platform to deliver targeted nutrition and improve ICU outcomes.
Methods:
Critically ill patients ≥18 years-old, mechanically ventilated and enterally fed, were randomized to receive ESPEN-guideline-based nutrition or smART+ -guided nutrition for 2-14 days. Primary endpoint was average deviation from daily targeted nutrition determined via calculation of energy targets per calorimetry. Secondary endpoints included gastric residual volumes, length of stay (LOS) and length of ventilation (LOV).
Results:
smART+ achieved a mean deviation from daily targeted nutrition of 10.5% (n = 48) versus 34.3% for control (n = 50), p < 0.0001. LOS and LOV were decreased in the smART+ group versus control (mean LOS: 10.4 days versus 13.7; reduction 3.3 days, adjusted HR 1.71, 95% CI:1.13,2.60, p = 0.012; mean LOV: 9.5 days versus 12.8 days reduction of 3.3 days, adjusted HR 1.64, 95% CI:1.08-2.51, p = 0.021). Feeding goals were met (within ±10%) on 75.7% of days for smART+ versus 23.3% for control (p < 0.001). No treatment-related adverse events occurred in either group. The study was stopped due to success in a planned interim analysis of the first 100 patients.
Conclusion:
The smART+ Platform improved adherence to feeding goals and reduced LOS and LOV versus standard of care in critically ill patients.
Trial Registration:
NCT04098224; registered September 23, 2019.
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