NCT07343440 Trial on the Impact of Indirect Calorimetry-Guided Nutritional Support on Patient-Centered Outcomes in Critically Ill Patients - The OPTICal Study
| NCT ID | NCT07343440 |
| Status | Recruiting |
| Phase | — |
| Sponsor | HEIDEGGER CP |
| Condition | Critical Illness |
| Study Type | INTERVENTIONAL |
| Enrollment | 356 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 356 participants in total. It began in 2026-01-01 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: All patients admitted to the ICU with the following criteria: * ≥18 years old * On Mechanical Ventilation * Expected ICU length of stay \>72 hours Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07343440 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07343440 currently recruiting?
Yes, NCT07343440 is actively recruiting participants. Contact the research team at claudia.heidegger@hug.ch for enrollment information.
Where is the NCT07343440 trial being conducted?
This trial is being conducted at Geneva, Switzerland, Nyon, Switzerland, Zurich, Switzerland.
Who is sponsoring the NCT07343440 clinical trial?
NCT07343440 is sponsored by HEIDEGGER CP. The trial plans to enroll 356 participants.