Peptamen 1.5% via enteralProsol 20% IV to 1.75g/kg/dayProsol 20% IV to 2.5g/kg/day
Peptamen 1.5% via enteral: Study patients in this group will be prescribed 1.0 g/kg/d of protein using standard enteral Peptamen 1.5%. Based on current compliance or tolerance statistics, investigators expect patients to only receive 50-60% of these prescribed doses; effective protein intake will therefore be approximately 0.5-0.6 g/kg/d.
Prosol 20% IV to 1.75g/kg/day: Patients in group 2 will receive Peptamen 1.5% but in addition, will receive sufficient intravenous amino acid supplements (Prosol 20%) to achieve an effective fixed dose of 1.75 g/kg/day.
Prosol 20% IV to 2.5g/kg/day: Patients in this group will receive intravenous amino acids, Prosol 20% in addition to standard enteral Peptamen 1.5% to achieve an effective protein intake of 2.5 g/kg/d.
Study summary
Enhancing the anabolic effect of nutrition in critically ill patients by administering exogenous amino acids.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Mechanically ventilated adult patients (\>18 years old) admitted to ICU with an expected ICU dependency (alive and need for mechanical ventilation
* Vasopressor therapy, or mechanical circulatory support) at the point of screening of an additional 3 days, as estimated by the treating physician.
Exclusion Criteria:
* Patients who are moribund (expected death within 48 hours)
* Expected to have life-sustaining treatments withdrawn in the next 3 days
* Those with a contraindication to enteral nutrition (EN)
* Already on parenteral nutrition (PN)
* Those with acute fulminant hepatitis or severe chronic liver disease (Child's class C)
* Patients on extracorporeal membrane oxygenation or carbon dioxide removal\* Patients with organ transplantation
* Those with a broncho-pleural fistula
* Patients with documented allergies to any of the study nutrients or its excipients will be excluded.
* Patients requiring continuous renal replacement therapy or extracorporeal membrane oxygenation are excluded due to inability to accurately measure protein turnover.
Primary outcome measure(s)
Whole body protein balance — 0 and 48 hours Primed continuous infusions of stable isotope tracers will be applied to assess dynamic changes in whole body and hepatic protein metabolism (i.e., protein breakdown, amino acid oxidation, protein synthesis, total protein, albumin and fibrinogen synthesis) before 48 hours after beginning the intervention. During the period of isotope infusion, nutrition will be held constant. A positive protein balance (difference between protein synthesis and protein breakdown) will be used as an indicator of whole body anabolism. All isotopes will be purchased from CDN Laboratories (Montreal, Canada). Sterile solutions will be tested to be free of pyrogens. Before beginning each experiment blood and expired air samples will be collected to determine baseline enrichments of \[1-13C\]-ketoisocaproate (\[1-13C\]-KIC), \[6,6-2H2\]glucose, L-\[2H5\]phenylalanine and expired 13CO2. Retention of H13CO3- in the bicarbonate pool will be measured in each patient using the approach of Kien.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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