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

Официальное название

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

Обзор

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.

Вмешательства

• Другое Indirect 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
• Другое Control Group - Formula-Based Group
  * Nutritional targets determined using predictive equations (pragmatic, set at local level) * Escalation as per local protocol

Первичные конечные точки

• Quality of life (EQ-5D-5L) [Срок оценки: At 3 months after ICU admission]

Вторичные конечные точки (12)

• Mortality [Срок оценки: Up to 3 months after ICU admission]
• Nosocomial infection [Срок оценки: Up to 28 days after ICU admission]
• Pressure soar [Срок оценки: Up to 28 days after ICU admission]
• Energy deficit in kcal [Срок оценки: Up to 28 days after ICU admission]
• Protein deficit in grams [Срок оценки: Up to 28 days after ICU admission]
• Ventilation-free days [Срок оценки: Measured at day 28 after ICU admission]
• ICU free-days [Срок оценки: Measured at day 28 after ICU admission]
• Functional recovery: Bartel Index [Срок оценки: At ICU discharge or up to 28 days after ICU admission and at 3 months after ICU discharge]
• Gerneral well-being: Edmonton Symptom Assessment Scale [Срок оценки: At ICU discharge or up to 28 days after ICU admission and at 3 months after ICU discharge]
• Readmission and rehospitalization rates [Срок оценки: Until 3-month post-ICU admission]
• Discharge place [Срок оценки: Until 3 months after ICU admission]
• Return to work [Срок оценки: Until 3 months after ICU admission]

Критерии участия

Критерии включения

All patients admitted to the ICU with the following criteria:

• ≥18 years old
• On Mechanical Ventilation
• Expected ICU length of stay >72 hours

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Швейцария · 3 центра

• Geneva University Hospital — Geneva
• GHOL — Nyon
• Zürich University Hospitals — Zurich

Идентификаторы

NCT: NCT07343440 · OPTICal2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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