EFFORTcomboThe Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Randomized Trial
OLIMEL 7,6%E / PeriOLIMEL 2,5%E
Fragilidad+7
+ Atrofia
+ Atrofia Muscular
Estudio de Prevención
Resumen
Fecha de inicio: 1 de junio de 2020
Fecha en la que se inscribió al primer participante.Positive, neutral, or negative, the results of the EFFORTcombo study will inform the clinical practice in ICU settings around the world. If positive, because of the pragmatic, multicentre nature of this trial, results will be broadly applicable to all critically ill patients worldwide. If the results are negative, it will be ensured that patients no longer receive high-dose protein/amino acid admixtures or possibly, combined EN/PN. As it relates to critical care nutrition practice in general, there is a long history of practice-changing initiatives. A process of synthesizing (in the form of evidence-based clinical practice guidelines) and disseminating best practice ideas (in the form of web-based repository of tools and information \[see www.criticalcarenutrition.com\]) was established. Over the past several years, this program of research with leaders of the American Society of Parenteral and Enteral Nutrition (ASPEN) and this specific protocol at the annual Clinical Nutrition Week with society leaders, researchers, and the clinical nutrition community at large has been discussed. Partnership with ASPEN will further facilitate both, recruitment initiatives and, importantly, the knowledge translation initiatives. These efforts will increase the likelihood of the uptake of EFFORT results across the world. This study has both the potential to answer a high-priority clinical question and also transform the new approach in clinical nutrition research. It further represents a unique collaboration between ASPEN, its global partners, and the Clinical Evaluation Research Unit, a methodological support center based in Kingston, Ontario, Canada and managed by Dr. Daren Heyland. If successful, this type of collaboration sets an important precedent for how this community may approach additional research questions related to clinical nutrition. Nested within this larger volunteer-driven registry trial, the aim is to complete a significant sub-study that will establish the role of combined EN/PN in these nutritionally high-risk patients. This protocol pertains to the specifics of this sub-study of combined EN/PN. At the end of the trial, the data from this sub-study will be merged into the results of the overall parent EFFORT Trial (where data points are similar).
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Estudio de Prevención
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: 1. ≥18 years old; 2. Expected to remain mechanically ventilated for an additional 48 hours from screening; 3. And have one or more of the following risk factors that make them at high nutritional risk: 1. Low (≤25) or High BMI (≥35) 2. Moderate to severe malnutrition (as defined by local assessments). We will document the means by which sites are making this determination and capture the elements of the assessment (history of weight loss, history of reduced oral intake, etc.). 3. Frailty (Clinical Frailty Scale 5 or more from proxy) 4. Sarcopenia (SARC-F score of 4 or more from proxy) 5. From point of screening, projected duration of mechanical ventilation \>4 days Exclusion Criteria: 1. \>96 continuous hours of mechanical ventilation before enrollment 2. Expected death or withdrawal of life-sustaining treatments within 7 days from screening 3. Pregnancy 4. The responsible clinician feels that the patient either needs low or high protein 5. Absolute contraindication to EN 6. Severe metabolic disorders including electrolyte disorders, uncontrolled hyperglycemia, hyperlipidemia, hypophosphatemia. 7. Severe chronic liver disease (MELD-score \>20) or acute fulminant hepatitis. 8. Metabolic disorders involving impaired nitrogen utilization 9. Not ambulating independently prior to illness that lead to ICU admission (use of gait aid permitted) 10. Lower extremity injury or impairments that prevents them walking prior to hospital discharge (e.g. amputation, knee/hip injury) 11. Pre-existing cognitive impairment or language barrier that prohibits outcomes assessment 12. Pre-existing primary severe systemic neuromuscular disease resulting in severe weakness pre-ICU (e.g., Guillain Barre) 13. Intracranial or spinal process affecting motor function 14. Patients in hospital \>5 days prior to ICU admission
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación