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| Name | Class |
|---|---|
| University Hospital, Zürich | OTHER |
| GHOL Nyon Hospital | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group - Indirect Calorimetry Group | Experimental |
| |
| Control Group - Formula-Based Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indirect Calorimetry Group | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (EQ-5D-5L) | Measured using the EQ-5D-5L: 0-100 | At 3 months after ICU admission |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Up to 3 months after ICU admission | |
| 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 |
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Inclusion Criteria:
All patients admitted to the ICU with the following criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claudia Paula Heidegger, Prof. | Contact | +41223727440 | claudia.heidegger@hug.ch | |
| Aude de Watteville, MSc | Contact | +41795533998 | aude.dewatteville@hug.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geneva University Hospital | Recruiting | Geneva | Switzerland |
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| Control Group - Formula-Based Group | Other |
|
|
| Up to 28 days after ICU admission |
| Pressure soar | Up to 28 days after ICU admission |
| Energy deficit in kcal | according to the energy target defined by IC or predictive formula depending on the randomization group | Up to 28 days after ICU admission |
| Protein deficit in grams | according to the protein target defined by predictive formula | 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 | Using Barthel Index: 0-100 | 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 | Using Edmonton Symptom Assessment Scale (ESAS) : 0-90 | 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 | Using WHO Disability Assessment Schedule (WHODAS 2.0): 0-48 | At 3-month post ICU admission |
| Disability and functioning: Clinical Frailty Scale | Using Clinical Frailty Scale (CFS): 1-9 | At 3-month post ICU admission |
| Disability and functioning: Short-form 12 | Using Short-form 12 (SF-12): 0-100 | At 3-month post ICU admission |
| Disability and functioning: MOCA-5 | Using montreal cognitive assessment- 5 min (MOCA-5): 0-15 | At 3-month post ICU admission |
| Disability and functioning: Patient Health Questionnaire-9 | Using Patient Health Questionnaire-9 (PHQ-9): 0-27 | At 3-month post ICU admission |
| GHOL | Recruiting | Nyon | Switzerland |
|
| Zürich University Hospitals | Recruiting | Zurich | Switzerland |
|
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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