Design and rationale of the effect of early nutritional therapy on frailty, functional outcomes and recovery of malnourished medical inpatients trial (EFFORT): a pragmatic, multicenter, randomized-controlled trial
| Autor: | Philipp Schuetz, Sarah Sigrist, Michael Brändle, Beat Mueller, Silvia Mattmann, Christoph Henzen, Valerie Baechli, Carmen Benz, Jacques Donzé, Alexander Kutz, Zeno Stanga, Filomena Gomes, Nicolas Rodondi, Jonas Rutishauser, Drahomir Aujesky, Pascal Tribolet, Stefan Bilz, Claus Hoess, Sarah Schmid, Robert Thomann, Vojtech Pavlicek, Claudia Brand, Martina Geiser, Rebecca Fehr, Thomas Bregenzer |
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| Rok vydání: | 2018 |
| Předmět: |
Consensus algorithm
medicine.medical_specialty Dieticians business.industry 610 Medicine & health 030204 cardiovascular system & hematology medicine.disease law.invention 03 medical and health sciences Malnutrition 0302 clinical medicine Randomized controlled trial 360 Social problems & social services law Intervention (counseling) medicine 030212 general & internal medicine Medical nutrition therapy Intensive care medicine Trial registration business Nutritional risk |
| Zdroj: | Schuetz, Philipp; Fehr, Rebecca; Baechli, Valerie; Geiser, Martina; Gomes, Filomena; Kutz, Alexander; Tribolet, Pascal; Bregenzer, Thomas; Hoess, Claus; Pavlicek, Vojtech; Schmid, Sarah; Bilz, Stefan; Sigrist, Sarah; Brändle, Michael; Benz, Carmen; Henzen, Christoph; Mattmann, Silvia; Thomann, Robert; Brand, Claudia; Rutishauser, Jonas; ... (2018). Design and rationale of the effect of early nutritional therapy on frailty, functional outcomes and recovery of malnourished medical inpatients (EFFORT): a pragmatic, multicenter, randomized-controlled trial-Protocol. International Journal of Clinical Trials, 5(3), pp. 142-50. Medip Academy 10.18203/2349-3259.ijct20182085 |
| ISSN: | 2349-3259 2349-3240 |
| DOI: | 10.18203/2349-3259.ijct20182085 |
| Popis: | Background: Malnutrition is highly prevalent and strongly associated with clincial outcomes of medical inpatients. Still, the benefit of nutritional treatment to prevent adverse outcomes in medical inpatients at risk for malnutrition remains unproven. We describe the trial methods of the largest yet nutritional trial in medical inpatients including the rationale for key design decisions regarding the nutritional strategy, eligibility criteria, choice of control arm, and endpoints.Methods: The Effect of early nutritional therapy on Frailty, Functional Outcomes and Recovery of malnourished medical inpatients Trial (EFFORT) is an investigator-initiated, non-commercial, open-label RCT to compare the effects of an intensified nutritional therapy (intervention group) with a control group on medical outcomes. We include adult medical inpatients at risk of malnutrition based on a Nutritional Risk Screening 2002 (NRS) score of ≥3 points with an expected length of stay of ≥5 days. An individualized systematic nutritional assessment by study dieticians is done to define nutritional targets and to establish an implementation plan. Patients in the intervention group receive individualized early nutritional therapy based on a previously published consensus algorithm, while control group patients receive standard hospital nutrition. The study is powered to compare clinical outcomes (composite adverse outcome and mortality) in the 2 study arms as well as to address several mechanistical questions.Conclusion: EFFORT aims to close important gaps in the literature regarding the controversy about benefit and possible harm of nutritional therapy in medical inpatients at risk for malnutrition.Trial Registration: ClinicalTrials.gov NCT02517476; registered July 30, 2015. |
| Databáze: | OpenAIRE |
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