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

Not Applicable

Recruiting

• Conditions: Malnutrition; Trauma; Critical illness; Diet and Nutrition - Other diet and nutrition disorders; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12620001008910
• Lead Sponsor: Gold Coast University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-06
• Last Update Posted: 19 September 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

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
10Intracranial 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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified