None listed
Conditions
Brief summary
An ICU stay is associated with significant muscle wasting in up to 80% of critically ill patients. This muscle wasting results in ‘ICU-acquired weakness’ that is associated with slower weaning from ventilator support, longer time to discharge alive from ICU and hospital, higher in-hospital costs which persist well after discharge from the acute care setting. Nutrition therapy, usually delivered to ICU patients as liquid feed via a tube into the stomach. The provision of additional protein has the potential to improve at least part of the significant muscle atrophy that occurs, and hence enhance functional recovery from critical illness. A number of observational research studies have reported that a large proportion of ICU patients do not meet prescribed protein targets, with protein delivered closer to prescribed targets associated with reduced mortality, ventilation and ICU and hospital length of stay. Currently guidelines recommend delivery of protein doses of 1.2 - 2.0 g/kg/day or higher, but this is based on very low quality of evidence. Therefore, there is a need for high-quality randomised controlled trials of differing protein doses.
Interventions
Intervention enteral nutrition (EN) will be a higher protein formula produced by Nutricia with 1.25 kcal/ml and 100 g protein in 1000 ml bag. Study protocol EN will be delivered via naso-enteric tube for a maximum of 28 days. The goal rate for administration of protocol EN will be 1ml/kg of Ideal Body Weight (IBW)/hour, delivered over 24 hours/ day
The blinded protocol EN will cease if one of the following occur: cessation of EN by the treating clinicians before day 28, patient is discharged fr
Intervention enteral nutrition (EN) will be a higher protein formula produced by Nutricia with 1.25 kcal/ml and 100 g protein in 1000 ml bag. Study protocol EN will be delivered via naso-enteric tube for a maximum of 28 days. The goal rate for administration of protocol EN will be 1ml/kg of Ideal Body Weight (IBW)/hour, delivered over 24 hours/ day The blinded protocol EN will cease if one of the following occur: cessation of EN by the treating clinicians before day 28, patient is discharged from the ICU before day 28, treating clinician feels that it is in the patient’s best interest to cease the study intervention, consent is withdrawn before day 28, oral nutrition is commenced, additional enteral nutrition supplements are commenced, patient dies prior to day 28
Sponsors
Professor Marianne Chapman
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged greater than or equal to 18 years old 2. Receiving invasive mechanical ventilation 3. About to commence EN or EN commenced within the previous 12 hours 4. Expected to be receiving EN in ICU beyond the calendar day following randomisation
Exclusion criteria
1. Expected to be receiving any oral nutrition before the calendar day following randomisation 2. Any EN or PN received for >12 hours in any ICU admission in this hospital episode 3. Previously enrolled in this study 4. Treating clinician considers the EN goal rate (i.e. 1ml/kg of ideal body weight (IBW) per hour) to be clinically contraindicated e.g. requirement for fluid restriction 5. Treating clinician considers that either dose of protein delivered in this study is unsuitable for the patient. 6. Requirement for specific nutritional therapy as determined by the treating doctor or dietitian i.e. protocol EN not considered to be in the best interest of the subject
Outcome results
None listed