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NOT YET RECRUITING
NCT07343440
NA

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

Sponsor: HEIDEGGER CP

View on ClinicalTrials.gov

Summary

This multicentric randomized controlled trial aims to evaluate whether indirect calorimetry (IC)-guided nutritional support improves patient-centered outcomes in critically ill adult patients compared to standard formula-based nutritional strategies. The study includes mechanically ventilated patients expected to remain in the ICU for more than 72 hours. The intervention group will receive nutritional targets based on measured resting energy expenditure using the QNRG+ device, with a gradual escalation of energy delivery following current ESPEN guidelines. The primary outcome is quality of life at 3 months post-ICU admission, assessed using the EQ-5D-5L. Secondary outcomes include functional recovery, muscle preservation, infection rates, and rehospitalization. This study is the first to assess the long-term impact of IC-guided nutrition on recovery and quality of life using a patient-centered approach.

Official title: A Randomized Controlled Trial on the Impact of Indirect Calorimetry-Guided Nutritional Support on Patient-Centered Outcomes in Critically Ill Patients - The OPTICal Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

356

Start Date

2026-01-01

Completion Date

2027-09-01

Last Updated

2026-01-15

Healthy Volunteers

No

Interventions

OTHER

Indirect Calorimetry Group

* Nutritional targets measured by IC starting on Day 4 * Repeated IC measurements 2 times weekly performed with the QNRG+ device * Gradual escalation to 80%-100% caloric coverage by Day 4

OTHER

Control Group - Formula-Based Group

* Nutritional targets determined using predictive equations (pragmatic, set at local level) * Escalation as per local protocol

Locations (3)

Geneva University Hospital

Geneva, Switzerland

GHOL

Nyon, Switzerland

Zürich University Hospitals

Zurich, Switzerland