Delivering a higher-protein diet for Trauma Patients (Ignite)

INTERVENTION: Currently, protein prescriptions for critically ill patients range from 0.5‐3.8 g/kg/d. There is an insufficient evidentiary basis to establish which level of protein administration is right for which patient population. We will take usual practices (following the current ICU Nutrition guideline of Gold Coast Health) and create two groups randomising eligible patients to a lower prescription (equal to 1.2 g/kg/d) or to a higher prescribed protein intake (equal to 2.2 g/kg/d) for the duration of their ICU admission. Following randomisation, prescription according to group assignment will be undertaken by the ICU dietitian or ICU medical team with the intervention administered by ICU nurses as part of patient care practices. In both groups, targets will be set using pre‐ICU dry actual weight. For patients with BMI greater than 30, ideal body weight based on a BMI of 25 will be used. For the higher protein group, we will use Nutrison Protein Intense (Nutricia; 10g protein/100ml) which provides a higher protein to energy ratio in line with current guidelines. The control group will receive Nutrison Protein Plus Multifibre (Nutricia; 6.3g/100ml). Enteral feeding solutions for both groups will be delivered as a continuous infusion. Once on the ward, protein supplementation will continue by providing high protein oral nutrition supplement (Resource 2.0; Nestlé Health Science) which will provide an additional 19.7g of protein in one 237ml supplement (an additional 40g of protein per day). In the event that flavour fatigue occurs, alternative protein supplementation will be prescribed using higher protein food supplements such as Up n Go Protein Energize (Sanitarium; 16.8g per serve), Quest Protein bars (Quest Nutrition; 21g protein), Chobani Fit high protein yoghurt (Chobani; CONDITION: Diet and Nutrition ‐ Other diet and nutrition disorders Injuries and Accidents ‐ Other injuries and accidents Malnutrition;Trauma;Critical illness; ; Malnutrition ; Trauma ; Critical illness INCLUSION CRITERIA: Critically injured mechanically ventilated adult trauma patients (18 years of age or older) expected to remain mechanically ventilated for an additional 48 hours from screening and have one or more of the following risk factors that make them at high nutritional risk: 1. Low (at or below 25) or High BMI (at or above 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 more than 4 days PRIMARY OUTCOME: Acceptability of the study interventions and outcome measurements will be determined through qualitative interviews (guided by the Theoretical Domains Framework) with patients and/or family members, and health professionals. The interviews will be undertaken to identify factors influencing intervention implementation (including its acceptability to patients and/or family members and staff). Interviews, either group or individual, conducted face‐to‐face or by telephone, will be audio recorded and transcribed verbatim. [ Prior to hospital discharge ] Study feasibility is the primary (composite) outcome as defined by:; • >75% of patients enrolled in the study under delayed consent, for whom consent to continue is obtained once the patient is discharged from ICU will be determined from study data; • >75% of patients assigned to the intervention group will receive at least 2.2g/kg/day of protein as prescribed which will be determined using data from the study database will be determined from routinely collected hospital data; • >75% of outcome measures are able to be collected from patients who survive to hospital discharge will be determined from study data; • >75% of patients are able to complete outcome measures at 6‐months via the phone‐based follow up will be determined from study data.; [Time points for feasiblity assessment are at 1) hospital discharge and 2) 6 month follow up.] SECONDARY OUTCOME: 60‐day mortality, This will be assessed from medical records.[Assessed once 60 days post admission.] Anxiety will be assessed using the Hospital Anxiety and Depression Scale as part the recommended Core Outcome Measurement Set for evaluating post‐discharge outcomes in acute respiratory failure survivors.[6 month phone based follow up post hospital discharge.] Cognitive function will be measured using Montreal Cognitive Assessment‐BLIND screening questionnaire (assessment of attention and concentration, memory, language, conceptual thinking, calculations, and orientation) as part the recommended Core Outcome Measurement Set for evaluating post‐discharge outcomes in acute respiratory failure survivors.[6 month phone based follow up post hospital discharge.] Depression will be assessed using the Hospital Anxiety and Depression Scale as part the recommended Core Outcome Measurement Set for evaluating post‐discharge outcomes in acute respiratory failure survivors.[6 month phone based follow up post hospital discharge.] Distal strength measured via isometric hand grip strength via a hydraulic hand dynamometer performed bilaterally as per American Society of Hand Therapist guidelines and evaluated using age and gender normal values (adult males 35.1 ‐55.5kg; adult females 24.5‐41.4kg).[Once at ICU discharge and once at hospital discharge.] Duration of mechanical ventilation data extracted from medical chart[Daily throughout ICU admission. ] Functional Status Score for ICU (FSS‐ICU), which is a 5‐item (rolling, transfer from spine to sit, sitting at the edge of bed, transfer from sit to stand, and walking). Each task is evaluated using an 8‐point ordinal scale ranging from 0 (not able to perform) to 7 (complete independence designed for ICU patients and was designed and is responsive to change during recovery for ICU patients. The total FSS‐ICU score ranges from 0 to 35, with higher scores indicating better physical functioning.[Once at ICU discharge and once at hospital discharge.] Health related quality of life (QOL) will be measured using SF‐36 version 2 (SF‐36 v2) and EQ‐5D‐5L. The SF‐36 is valid and reliable across a variety of patient groups, including ICU survivors. The EQ‐5D‐5L is included, in addition to SF‐36 v2, because it is suitable for patients with inattention and fatigue recommended for use in ICU survivors[6 month phone based follow up post hospital discharge.] ICU length of stay data extracted from medical chart[Assessed once post hospital discharge..] Muscle quality[We will collect baseline ultrasound (US) measures of muscle quality (architecture and evidence of myonecrosis) (within 24 hours of randomisation, 10 days post randomisation – if the patient is still in hospital, and just prior to hospital discharge). In the event that hospital discharge is prior to day 10, the day 10 measure will not be done. ] Muscle quantity measured by quadriceps ultrasound. [We will collect baseline ultrasound (US) measures of muscle mass and cross‐sectional area (within 24 hours of randomisation, 10 days post randomisation – if the patient is still in hospital, and just prior to hospital discharge). In the event that hospital discharge is prior to day 10, the day 10 measure will not be done. ] Nutritional adequacy data will be calculated from data extracted from medical chart and calculated as the proportion of prescribed nutrition received by the patient. [Daily throughout ICU admission. ; On ward: 3 day calorie count continues weekly until the patient is discharged from hospital or for a maximum of 4 weeks, whichever comes first.] Overall physical strength using Medical Research Council (MRC) sum‐score evaluated via standardized “manual muscle testing” with each of 12 muscle groups assessed using a 6‐point MRC scale and summed to a total score (range: 0‐60). Upper muscle groups are assessed through shoulder abduction, elbow flexion and wrist extension; lower muscle groups are assessed through hip flexion, knee extension and ankle dorsiflexion. [Once prior to hospital discharge.] Physical functional status will be measured using Lawton’s Instrumental ADL (IADL) scale. [6 month phone based follow up post hospital discharge.] Physical functional status will be measured using Katz activities of daily living (ADL) scale. [6 month phone based follow up post hospital discharge.] Post‐traumatic stress disorder will be measured using the Impact of Events Scale‐Revised as part the recommended Core Outcome Measurement Set for evaluating post‐discharge outcomes in acute respiratory failure survivors.[6 month phone based follow up post hospital discharge.] Quadriceps force, via hand‐held dynamometry (HHD) of both lower extremities. Each will be scored by, averaging the results of three trials.[Once at ICU discharge and once at hospital discharge.] Readmission to hospital data extracted from medical chart[Assessed once 30 days post hospital discharge ] Readmission to ICU data extracted from medical chart.[Assessed once post hospital discharge.] Short Physical Performance Battery (SPPB) is a composite measure of physical function which measures balance, walking speed, and rising from a chair.[Once at ICU discharge and once at hospital discharge.] Time to discharge alive from hospital will be assessed from medical records.[Assessed once post hospital discharge.] Walking distance achieved during a 6‐minute walk test (6MWT) . Implementation of the test will be based upon the 2014 ATS standards, with adaptation, as needed, for the in‐patient setting and ICU survivor population. The 6MWT is a reliable, valid, responsive measure of physical function for survivors of acute respiratory failure.[Measured at hospital discharge.]