Randomized Trial of Indirect Calorimetry-Guided Nutrition Versus Formula-Based Nutrition in Critically Ill Adults Evaluating Quality of Life and Recovery After ICU Care

What this Trial Is About

Researchers are evaluating whether nutritional support guided by indirect calorimetry improves recovery and quality of life in critically ill adult patients compared to standard formula-based nutrition. This multicenter randomized controlled trial focuses on mechanically ventilated patients expected to stay in the ICU for more than 72 hours. The study aims to assess patient-centered outcomes, including quality of life measured three months after ICU admission, functional recovery, muscle preservation, infection rates, and rehospitalization. Participants are randomly assigned to one of two groups. The intervention group receives nutrition targets based on resting energy expenditure measured by the QNRG device starting on Day 4, with repeated measurements twice weekly and gradual escalation to 80%-100% caloric coverage by Day 4 according to ESPEN guidelines. The control group receives nutrition based on predictive equations and local protocols for escalation. The study spans the ICU stay and follows patients for three months post-admission. During the study, researchers will assess quality of life at three months using the EQ-5D-5L tool and track secondary outcomes such as mortality, infection, pressure sores, energy and protein deficits, ventilator and ICU-free days, functional recovery, symptom assessment, rehospitalization, discharge location, return to work, and various disability and functioning scales. Data collection includes regular calorimetry measurements and clinical evaluations throughout the ICU stay and follow-up period, lasting up to three months after ICU admission.

Trial on the Impact of Indirect Calorimetry-Guided Nutritional Support on Patient-Centered Outcomes in Critically Ill Patients - The OPTICal Study