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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
SINGLE
Enrollment
203
1. Initiation of early supplementary parenteral nutrition (≤ 24 hours of admission). 2. Measurement of requirements (indirect calorimetry, 24-hour urinary urea) leading to patient-specific, individualised and goal-directed nutritional therapy. 3. Intervention goal: delivering 100% of patient-specific requirements, measured or calculated throughout entire admission (EN+PN).
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.
Department of Intensive Care, Rigshospitalet
Copenhagen, Denmark
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
Time frame: 6 months after randomisation
Mortality
Time frame: 28 days
Mortality
Time frame: 90 days
Mortality
Time frame: 6 months
Survival status for all patients
Time frame: 6 months
New organ failure in the ICU
SOFA score above 3 in every category ex. Glasgow Coma Scale Score
Time frame: 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)
Time frame: Followed until ICU discharge, an expected average of 21 days
New onset of renal replacement therapy
Time frame: Followed until ICU discharge, an expected average of 21 days
Accumulated energy- and protein balance
Time frame: Followed until ICU discharge, an expected average of 21 days
Length of stay in ICU
Among survivors
Time frame: Up to 52 weeks
Length of stay in hospital
Among survivors
Time frame: Up to 52 weeks
Serious adverse reactions in ICU
Severe allergic reactions or elevated levels of liver enzymes in plasma
Time frame: Up to 52 weeks
Health related quality of life
Assessed by SF-36 questionnaire
Time frame: 6 months after randomisation
Rate of nosocomial infections
Defined in six subcategories by a person blinded for the intervention
Time frame: Followed until ICU discharge, an expected average of 21 days
Percent days alive without inotropic/vasopressor support at day 90
Time frame: Up to 90 days
Percent days alive without renal replacement therapy at day 90
Time frame: Up to 90 days
Percent days alive without mechanical ventilation at day 90
Time frame: Up to 90 days
Cost analyses
Time frame: Up to 52 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.