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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHEIDEGGER CP

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

≥18 years old

On Mechanical Ventilation

Expected ICU length of stay >72 hours

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Indirect Calorimetry Group

    Other intervention

    * 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

  • Control Group - Formula-Based Group

    Other intervention

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

Treatment groups

356 Participants
are divided into 2 treatment groups
Group A: Intervention Group - Indirect Calorimetry GroupExperimental treatment 1 intervention
Group B: Control Group - Formula-Based GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Quality of life (EQ-5D-5L)

Measured using the EQ-5D-5L: 0-100

Time frame
At 3 months after ICU admission

Secondary outcomes

1

Mortality

Time frame
Up to 3 months after ICU admission
2

Nosocomial infection

Defined as the initiation of a new antibiotic treatment lasting at least 72 hours, associated with a documented diagnosis of infection in the patient's chart

Time frame
Up to 28 days after ICU admission
3

Pressure soar

Time frame
Up to 28 days after ICU admission
4

Energy deficit in kcal

according to the energy target defined by IC or predictive formula depending on the randomization group

Time frame
Up to 28 days after ICU admission

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HEIDEGGER CP

Lead sponsor

University Hospital, Geneva

Sponsor institution

University Hospital, Zürich

Collaborator

GHOL Nyon Hospital

Collaborator