RecruitingNot ApplicableNCT07343440

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

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


Sponsor

HEIDEGGER CP

Enrollment

356 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • All patients admitted to the ICU with the following criteria:
  • ≥18 years old
  • On Mechanical Ventilation
  • Expected ICU length of stay >72 hours

Exclusion Criteria7

  • Refusal of the family or patient
  • Patient transferred from another ICU
  • Pregnant patient
  • Patient is planned for a withdrawal of care or is actively dying
  • Cognitive disorder before ICU
  • Patient is in jail
  • Patients already enrolled in the ongoing NutriPhyT trial

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Interventions

OTHERIndirect 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

OTHERControl 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

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NCT07343440


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