CompletedPhase 2ACTRN12618001829202

TARGET Protein Feasibility Study: a prospective, blinded, parallel group, randomised controlled trial to assess the feasibility of conducting a phase III trial of protein targets in critically ill adults


Sponsor

Professor Marianne Chapman

Enrollment

120 participants

Start Date

Apr 11, 2019

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria4

  • Aged greater than or equal to 18 years old
  • Receiving invasive mechanical ventilation
  • About to commence EN or EN commenced within the previous 12 hours
  • Expected to be receiving EN in ICU beyond the calendar day following randomisation

Exclusion Criteria6

  • Expected to be receiving any oral nutrition before the calendar day following randomisation
  • Any EN or PN received for >12 hours in any ICU admission in this hospital episode
  • Previously enrolled in this study
  • 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
  • Treating clinician considers that either dose of protein delivered in this study is unsuitable for the patient.
  • 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

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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

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


Locations(8)

The Alfred - Prahran

NSW,SA,VIC, Australia

Austin Health - Austin Hospital - Heidelberg

NSW,SA,VIC, Australia

Frankston Hospital - Frankston

NSW,SA,VIC, Australia

The Royal Adelaide Hospital - Adelaide

NSW,SA,VIC, Australia

Royal Melbourne Hospital - City campus - Parkville

NSW,SA,VIC, Australia

The Queen Elizabeth Hospital - Woodville

NSW,SA,VIC, Australia

Royal Prince Alfred Hospital - Camperdown

NSW,SA,VIC, Australia

Wellington Region, New Zealand

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