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

HEIDEGGER CP

Status: Not yet enrolling

Conditions: ICU; Critical Illness

Treatments: Other: Control Group - Formula-Based Group; Other: Indirect Calorimetry Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07343440

OPTICal2025

Details and patient eligibility

About

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.

Enrollment: 356 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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356 participants in 2 patient groups

Intervention Group - Indirect Calorimetry Group

Experimental group

Treatment:

Other: Indirect Calorimetry Group

Control Group - Formula-Based Group

Active Comparator group

Treatment:

Other: Control Group - Formula-Based Group