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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
| Fresenius Kabi | INDUSTRY |
| European Society for Clinical Nutrition and Metabolism | OTHER |
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An increasing number of patients survive critical illness and intensive care, but describe having impaired physical function several years after discharge as a consequence of extensive loss of muscle mass. Reasons for loss of muscle mass and physical function are multiple, but insufficient nutrition is likely to contribute.
This randomised trial will investigate the effect of an optimised nutrition therapy during intensive care, on short term clinical outcome and physical quality of life. We hypothesise, that early nutritional therapy, directed towards patient-specific goals for energy and protein requirements, will improve both short- and long-term outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Goal-Directed Nutrition | Experimental |
| |
| ASPEN-guidelines | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Goal-Directed Nutrition | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical function | Physical function 6 months after randomisation (physical component summary (PCS)-score of SF-36, conducted as phone-interview by a person blinded to the intervention | 6 months after randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 28 days | |
| Mortality | 90 days | |
| Mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Perner, Professor, MD, PhD | Rigshospitalet, Department of Intensive Care | Principal Investigator |
| Matilde Jo Allingstrup, PhD Fellow, MSc | Rigshospitalet, Department of Intensive Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Intensive Care, Rigshospitalet | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28936712 | Derived | Allingstrup MJ, Kondrup J, Wiis J, Claudius C, Pedersen UG, Hein-Rasmussen R, Bjerregaard MR, Steensen M, Jensen TH, Lange T, Madsen MB, Moller MH, Perner A. Early goal-directed nutrition versus standard of care in adult intensive care patients: the single-centre, randomised, outcome assessor-blinded EAT-ICU trial. Intensive Care Med. 2017 Nov;43(11):1637-1647. doi: 10.1007/s00134-017-4880-3. Epub 2017 Sep 22. | |
| 27585532 |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D009135 | Muscular Diseases |
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009140 | Musculoskeletal Diseases |
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|
| ASPEN-guidelines | Other | EN will be the preferred route of nutrition, and will be initiated within the first 24 hours of ICU admission, in accordance with best evidence. The amount is gradually increased over the first days of admission as tolerated by the patient (assessed from gastric aspirates). If EN fails to reach calculated goals at day 7, supplementary PN will be initiated at admission day 8 to reach goals. Protein and energy goals will be calculated as 25 kcal/kg/day and 1.2 g protein/kg/day. |
|
| 6 months |
| Survival status for all patients | 6 months |
| New organ failure in the ICU | SOFA score above 3 in every category ex. Glasgow Coma Scale Score | Followed until ICU discharge, an expected average of 21 days |
| Metabolic control | Accumulated insulin administration to maintain B-glucose ≤10 mmol/l and rates of severe hyper- and hypoglycaemia (B-glucose >15 mmol/l or ≤2.2 mmol/l, respectively) | Followed until ICU discharge, an expected average of 21 days |
| New onset of renal replacement therapy | Followed until ICU discharge, an expected average of 21 days |
| Accumulated energy- and protein balance | Followed until ICU discharge, an expected average of 21 days |
| Length of stay in ICU | Among survivors | Up to 52 weeks |
| Length of stay in hospital | Among survivors | Up to 52 weeks |
| Serious adverse reactions in ICU | Severe allergic reactions or elevated levels of liver enzymes in plasma | Up to 52 weeks |
| Health related quality of life | Assessed by SF-36 questionnaire | 6 months after randomisation |
| Rate of nosocomial infections | Defined in six subcategories by a person blinded for the intervention | Followed until ICU discharge, an expected average of 21 days |
| Percent days alive without inotropic/vasopressor support at day 90 | Up to 90 days |
| Percent days alive without renal replacement therapy at day 90 | Up to 90 days |
| Percent days alive without mechanical ventilation at day 90 | Up to 90 days |
| Cost analyses | Up to 52 weeks |
| Derived |
| Allingstrup MJ, Kondrup J, Wiis J, Claudius C, Pedersen UG, Hein-Rasmussen R, Jensen TH, Lange T, Perner A. Early goal-directed nutrition in ICU patients (EAT-ICU): protocol for a randomised trial. Dan Med J. 2016 Sep;63(9):A5271. |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |