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

Feasibility of delivering a higher-protein diet to critically-injured patients (Ignite)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001008910
Acronym
Ignite
Enrollment
38
Registered
2020-10-06
Start date
2021-03-09
Completion date
2023-10-31
Last updated
2022-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Aim: To evaluate the feasibility of a randomised controlled trial of critically injured patients with nutrition risk factors where intervention group patients receive a higher dose (equal to 2.2 grams/kg/day) of protein/amino acid administration in ICU and a high protein oral nutrition supplement (ONS) on the ward; control patients receive 1.2 gram/kg/day of protein in the ICU and ONS on the ward as prescribed at the discretion of the treating team. Secondary aim: To contribute ICU data to the EFFORT trial which, is a large, multicenter, pragmatic, registry-based, patient randomised, clinical trial of 4000 nutritionally high-risk critically ill patients. In this study the administration of lower dose of protein/amino acids (equal to 1.2g/kg/day) will be compared with the administration of a higher dose of protein/amino acids (equal to 2.2g/kg/day) to nutritionally high-risk critically ill patients to determine if higher protein administration is associated with greater muscle mass, improved survival and a quicker rate of recovery. Hypothesis: We hypothesise that the trial will be feasible as judged by enrolment rates, intervention fidelity and protocol compliance

Interventions

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

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; 15 g). Intervention adherence in ICU is monitored as part of the clinical trial by reporting nutritional adequacy (proportion of prescribed nutrition received). When the patient is discharged to the ward, we will monitor (though chart audit and direct observation) the prescription, delivery and consumption of oral nutrition supplements in the intervention group to assess compliance with the study intervention. We will also collect consumption of ONS in the control group (both product and protein consumed) for the control group to assess the degree of treatment differentiation. Although this trial is not about caloric dose, we want to encourage participating clinicians to be conservative in meeting energy targets and avoid overfeeding. Caloric goals should be the same in both groups. We will endorse the guidelines for energy targets set forth by American Society of Parenteral and Enteral Nutrition/ Society of Critical Care Medicine, especially as it pertains to the obese patient. For non-obese patients, we suggest that their caloric prescription be around 20-25 kcal/kg/day using a simple weight based formula. If the site chooses to use more sophisticated equations or indirect calorimetry, that is permissible. For obese patients, if indirect calorimetry is used, the goal of the nutritional prescription should be to provide energy not to exceed 65%–70% of measured requirements. If indirect calorimetry is unavailable or not used, consistent with the published guidelines, we suggest using the weight-based equation 11–14 kcal/kg actual body weight per day for patients with BMI in the range of 30–50 and 22–25 kcal/kg ideal body weight per day for patients with BMI >50. In both groups, targets will be achieved through any combination of enteral nutrition (high protein content in high group if available), protein supplements, and parenteral nutrition or amino acids only (as clinically available). The only difference between the two groups is the protein targets that are set. Similar efforts should be used in both groups to achieve at least 80% of these targets. The remainder of care provided to eligible patients will be at the discretion of ICU providers.

Sponsors

Gold Coast University Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

1. Greater than 96 continuous hours of mechanical ventilation before screening 2. Expected death or withdrawal of life-sustaining treatments within 7 days from screening 3. Pregnant 4. The responsible clinician feels that the patient either needs low or high protein 5. Patient requires parenteral nutrition only and site does not have products to reach the high protein dose group. 6. Not ambulating independently prior to illness that lead to ICU admission (use of gait aid permitted) 7. Lower extremity injury or impairments that prevents them walking prior to hospital discharge (e.g. amputation, knee/hip injury) 8. Pre-existing cognitive impairment or language barrier that prohibits outcomes assessment 9. Pre-existing primary severe systemic neuromuscular disease resulting in severe weakness pre-ICU (e.g., Guillain Barre 10 Intracranial or spinal process affecting motor function 11. Patients in hospital more than 5 days prior to ICU admission 12. Not expected to stay 4 days after enrolment 13 Patients with acute kidney injury as defined by meeting any of the KDIGO criteria and not receiving renal replacement therapy: i) increase in serum creatinine of 0.3 mg/dl (26.52 umol/L) within 48 hours, or ii) increase in serum creatinine to which is 1.5 times baseline (this change was made after enrolment of 36 participants).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026