Critical Illness, ICU
Conditions
Keywords
Nutrition, Indirect calorimetry, Nutrition therapy, Predictive formula
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.
Interventions
OTHERIndirect 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
OTHERControl Group - Formula-Based Group
* Nutritional targets determined using predictive equations (pragmatic, set at local level) * Escalation as per local protocol
Sponsors
HEIDEGGER CP
University Hospital, Zürich
GHOL Nyon Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (EQ-5D-5L) | At 3 months after ICU admission | Measured using the EQ-5D-5L: 0-100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | Up to 3 months after ICU admission | — |
| Nosocomial infection | Up to 28 days after ICU admission | 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 |
| Pressure soar | Up to 28 days after ICU admission | — |
| Energy deficit in kcal | Up to 28 days after ICU admission | according to the energy target defined by IC or predictive formula depending on the randomization group |
| Protein deficit in grams | Up to 28 days after ICU admission | according to the protein target defined by predictive formula |
| 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 | Using Barthel Index: 0-100 |
| 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 | Using Edmonton Symptom Assessment Scale (ESAS) : 0-90 |
| 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 | Using WHO Disability Assessment Schedule (WHODAS 2.0): 0-48 |
| Disability and functioning: Clinical Frailty Scale | At 3-month post ICU admission | Using Clinical Frailty Scale (CFS): 1-9 |
| Disability and functioning: Short-form 12 | At 3-month post ICU admission | Using Short-form 12 (SF-12): 0-100 |
| Disability and functioning: MOCA-5 | At 3-month post ICU admission | Using montreal cognitive assessment- 5 min (MOCA-5): 0-15 |
| Disability and functioning: Patient Health Questionnaire-9 | At 3-month post ICU admission | Using Patient Health Questionnaire-9 (PHQ-9): 0-27 |
Countries
Switzerland
Contacts
CONTACTClaudia Paula Heidegger, Prof.
CONTACTAude de Watteville, MSc
Outcome results
None listed