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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
The tight calorie control study (TICACOS): a prospective, randomized, controlled pilot study of nutritional support
Pierre Singer1, Ronit Anbar, Jonathan Cohen
1Department of General Intensive Care, Rabin Medical Center, Campus Beilinson, 49100, Petah Tikva, Israel. psinger@clalit.org.il
Purpose:
To determine whether nutritional support guided by repeated measurements of resting energy requirements improves the outcome of critically ill patients.
Methods:
This was a prospective, randomized, single-center, pilot clinical trial conducted in an adult general intensive care (ICU) unit. The study population comprised mechanically ventilated patients (n = 130) expected to stay in ICU more than 3 days. Patients were randomized to receive enteral nutrition (EN) with an energy target determined either (1) by repeated indirect calorimetry measurements (study group, n = 56), or (2) according to 25 kcal/kg/day (control group, n = 56). EN was supplemented with parenteral nutrition when required.
Results:
The primary outcome was hospital mortality. Measured pre-study resting energy expenditure (REE) was similar in both groups (1,976 ± 468 vs. 1,838 ± 468 kcal, p = 0.6). Patients in the study group had a higher mean energy (2,086 ± 460 vs. 1,480 ± 356 kcal/day, p = 0.01) and protein intake (76 ± 16 vs. 53 ± 16 g/day, p = 0.01). There was a trend towards an improved hospital mortality in the intention to treat group (21/65 patients, 32.3% vs. 31/65 patients, 47.7%, p = 0.058) whereas length of ventilation (16.1 ± 14.7 vs. 10.5 ± 8.3 days, p = 0.03) and ICU stay (17.2 ± 14.6 vs. 11.7 ± 8.4, p = 0.04) were increased.
Conclusions:
In this single-center pilot study a bundle comprising actively supervised nutritional intervention and providing near target energy requirements based on repeated energy measurements was achievable in a general ICU and may be associated with lower hospital mortality.
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