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ClinicalTrials.gov ID

NCT07343440

Lead Sponsor

HEIDEGGER CPOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

356Estimated

Last Update Posted

May 19, 2026Actual

Start Date

Jan 1, 2026Actual

Primary Completion Date

Jun 1, 2027Estimated

Completion Date

Sep 1, 2027Estimated

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

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.

• Critical Illness
• ICU

• Indirect Calorimetry Group
• Control Group - Formula-Based Group

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Other

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

HEIDEGGER CPOTHER

Collaborators

University Hospital, ZürichOTHER

GHOL Nyon HospitalUNKNOWN

mallory.moretbochatay@ghol.ch+41 (0)22 994 67 47