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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A00626-37 | Other Identifier | RCB number |
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The intervention becomes obsolete for participating centres pending regulatories.
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The main objective of this study is to evaluate the impact of the intervention of a dietician on the energy balance accumulated over seven days of intensive care.
Energy balance is defined as the difference between the target recommended energy and total calorie intake actually received.
This is a randomized-cluster study; participating centers are randomized into experimental and control groups.
The secondary objectives of this study are to compare the impact of the intervention of a dietician on:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control intensive care wards | No Intervention | This is a randomized cluster trial. The centers randomized into this arm will serve as controls. No interventions will be implemented for these centers. | |
| Experimental intensive care wards | Experimental | This is a randomized cluster trial. The centers randomized into this arm will designate a dietitian who will help the ward implement current recommendations for the nutrition of patients undergoing intensive care. Intervention: Designated dietitian for the ward |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Designated dietitian for the ward | Other | This is a randomized cluster trial. The centers randomized into this arm will designate a dietitian who will help the ward implement current recommendations for the nutrition of patients undergoing intensive care. |
| Measure | Description | Time Frame |
|---|---|---|
| Caloric deficit accumulated over 7 days | Caloric deficit accumulated over 7 days (kcal/kg) | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Average per day caloric deficit | Average per day caloric deficit (kcal/kg/day) | Day 7 |
| Caloric deficit accumulated during the ICU stay | Caloric deficit accumulated during the ICU stay (kcal/kg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saber Davide Barbar, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Jean-Yves Lefrant, MD, PhD | Centre Hospitalier Universitaire de Nīmes | Study Director |
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| ICU discharge (maximum of 28 days) |
| Average per-day protein deficit | Average per-day protein deficit (grams protein/kg/day) | Day 7 |
| Protein deficit accumulated over 7 days | Protein deficit accumulated over 7 days (grams protein/kg) | Day 7 |
| Protein deficit accumulated during the ICU stay | Protein deficit accumulated during the ICU stay (grams protein/kg) | ICU discharge (maximum of 28 days) |
| Average per day amounts of vitamins received | Day 7 |
| Average per day amounts of trace elements received | Day 7 |
| Average per day amounts of pharmaco nutrients received | Day 7 |
| Percentage of calories received by enteral route | daily average | Day 7 |
| Percentage of calories received by enteral route | accumulated over 7 days | Day 7 |
| Percentage of calories received by enteral route | accumulated over ICU stay | ICU discharge (maximum of 28 days) |
| Percentage of proteins received by enteral route | daily average | Day 7 |
| Percentage of proteins received by enteral route | accumulated over 7 days | Day 7 |
| Percentage of proteins received by enteral route | accumulated over ICU stay | ICU discharge (maximum of 28 days) |
| length of time spent on ventilator (hours) | ICU discharge (maximum of 28 days) |
| length of ICU stay (days) | ICU discharge (maximum of 28 days) |
| Number of days spent with (any) organ failure | ICU discharge (maximum of 28 days) |
| Number of days on antibiotics | ICU discharge (maximum of 28 days) |
| Mortality (yes/no) | Day 90 |
| Mortality (yes/no) | Day 180 |
| Presence/absence of on-catheter bacteremia | Day 7 |
| Presence/absence of on-catheter bacteremia | Day 28 |
| Presence/absence of on-catheter bacteremia | ICU discharge (maximum of 28 days) |
| Presence/absence of ventilator acquired pneumonia | Day 7 |
| Presence/absence of ventilator acquired pneumonia | Day 28 |
| Presence/absence of ventilator acquired pneumonia | ICU discharge (maximum of 28 days) |
| Presence/absence of other infections | Day 7 |
| Presence/absence of other infections | Day 28 |
| Presence/absence of other infections | ICU discharge (maximum of 28 days) |
| Presence/absence of bed sores | Day 7 |
| Presence/absence of bed sores | Day 28 |
| Presence/absence of bed sores | ICU discharge (maximum of 28 days) |
| Composite score for complications | Presence/absence of at least one of the following complications: on-catheter bacteremia, ventilator acquired pneumonia, other infections, bed sores | Day 7 |
| Composite score for complications | Presence/absence of at least one of the following complications: on-catheter bacteremia, ventilator acquired pneumonia, other infections, bed sores | Day 28 |
| Composite score for complications | Presence/absence of at least one of the following complications: on-catheter bacteremia, ventilator acquired pneumonia, other infections, bed sores | ICU discharge (maximum of 28 days) |
| Minimum observed glycemia | Day 7 |
| Minimum observed glycemia | ICU discharge (maximum of 28 days) |
| Maximum observed glycemia | Day 7 |
| Maximum observed glycemia | ICU discharge (maximum of 28 days) |
| Average observed glycemia | Day 7 |
| Average observed glycemia | ICU discharge (maximum of 28 days) |
| Presence/absence of a glycemia measure < 0.4 g/l | Day 7 |
| Presence/absence of a glycemia measure < 0.4 g/l | ICU discharge (maximum of 28 days) |
| Presence/absence of a glycemia measure > 1.8 g/l | Day 7 |
| Presence/absence of a glycemia measure > 1.8 g/l | ICU discharge (maximum of 28 days) |
| Presence/absence of hypertriglyceridemia | Day 7 |
| Presence/absence of hypertriglyceridemia | ICU discharge (maximum of 28 days) |
| Accumulated cost of enteral nutrition | Between Day 0 and ICU discharge (expected maximum of 28 days) |
| Accumulated cost of parenteral nutrition | Between Day 0 and ICU discharge (expected maximum of 28 days) |
| Accumulated cost of antibiotics | Between Day 0 and ICU discharge (expected maximum of 28 days) |
| Accumulated cost of sedation | Between Day 0 and ICU discharge (expected maximum of 28 days) |
| Presence/absence of diarrhea | Between Day 0 and ICU discharge (expected maximum of 28 days) |
| Accumulated cost of nutritional supplements | Between Day 0 and ICU discharge (expected maximum of 28 days) |
| Accumulated cost of ICU stay | Between Day 0 and ICU discharge (expected maximum of 28 days) |