A Randomized Controlled Trial on the Impact of Indirect Calorimetry-Guided Nutritional Support on Patient-Centered Outcomes in Critically Ill Patients - The OPTICal Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 356
- 试验地点
- 3
- 主要终点
- Quality of life (EQ-5D-5L)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients admitted to the ICU with the following criteria:
- •≥18 years old
- •On Mechanical Ventilation
- •Expected ICU length of stay >72 hours
排除标准
- •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
研究组 & 干预措施
Intervention Group - Indirect Calorimetry Group
干预措施: Indirect Calorimetry Group (Other)
Control Group - Formula-Based Group
干预措施: Control Group - Formula-Based Group (Other)
结局指标
主要结局
Quality of life (EQ-5D-5L)
时间窗: At 3 months after ICU admission
Measured using the EQ-5D-5L: 0-100
次要结局
- Mortality(Up to 3 months after ICU admission)
- Nosocomial infection(Up to 28 days after ICU admission)
- Pressure soar(Up to 28 days after ICU admission)
- Energy deficit in kcal(Up to 28 days after ICU admission)
- Protein deficit in grams(Up to 28 days after ICU admission)
- Ventilation-free days(Measured at day 28 after ICU admission)
- ICU free-days(Measured at day 28 after ICU admission)
- Functional recovery: Bartel Index(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(At ICU discharge or up to 28 days after ICU admission and at 3 months after ICU discharge)
- Readmission and rehospitalization rates(Until 3-month post-ICU admission)
- Discharge place(Until 3 months after ICU admission)
- Return to work(Until 3 months after ICU admission)
- Disability and functioning: WHO Disability Assessment Schedule(At 3-month post ICU admission)
- Disability and functioning: Clinical Frailty Scale(At 3-month post ICU admission)
- Disability and functioning: Short-form 12(At 3-month post ICU admission)
- Disability and functioning: MOCA-5(At 3-month post ICU admission)
- Disability and functioning: Patient Health Questionnaire-9(At 3-month post ICU admission)
研究者
HEIDEGGER CP
Prof
University Hospital, Geneva