Clinical trial NCT02865408: Amino Acid Nutrition in the Critically-ill
Official title: Enhancing the Anabolic Effect of Nutrition in Critically Ill Patients by Administering Exogenous Amino Acids
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness
Inflammation
Malnutrition
Keywords: Amino acids
critically-ill
catabolic
nutrition
anabolic
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Enhancing the anabolic effect of nutrition in critically ill patients by administering exogenous amino acids.

Detailed description: Critically-ill patients admitted to the intensive care unit are invariably catabolic and are commonly undernourished. Previous observational studies indicate that increased dietary administration of protein or essential amino acids might be associated with improved clinical outcomes. The investigators propose that the parenteral supplementation of intravenous amino acids in critically-ill patients will restore anabolic processes and that anabolism is associated with molecular markers of amino acid sensing and protein synthesis. The results from this study will establish biomarkers of anabolism (i.e., nutritional success) that can be used in future clinical trials on the use of amino acid supplementation in the critically-ill.

Eligibility criteria: 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* Expected to have life-sustaining treatments withdrawn in the next 3 days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 outcomes:
measure: Whole body protein balance
timeFrame: 0 and 48 hours
Secondary outcomes:
measure: Synthesis rates of hepatic secretory proteins (the total plasma protein pool, albumin, fibrinogen in %/d)
timeFrame: 0 and 48 hours
measure: Biomarker of amino acid restriction or repletion - ELISA (pg/ml)
timeFrame: 0, 12, 24, 36, 48, 72 hours
measure: Biomarker of amino acid restriction or repletion - mRNA detection (copy number/ml)
timeFrame: 0, 12, 24, 36, 48, 72 hours
measure: Biomarker of amino acid restriction or repletion - protein levels (fold increase in Western blot band density)
timeFrame: 0, 12, 24, 36, 48, 72 hours
measure: Metabolic Substrates (micromolar)
timeFrame: 0, 24, 36, 48, 72 hours
measure: Resting Energy Expenditure (kcal)
timeFrame: 0 and 48 hours
Other outcomes:
measure: ICU length of stay
timeFrame: 72 hours to 1 year
measure: Hospital length of stay
timeFrame: 72 hours to 1 year
measure: Ventilator-free days in ICU
timeFrame: 72 hours to 1 year
measure: Hospital-acquired infections.
timeFrame: 72 hours to 1 year
measure: Mortality
timeFrame: 72 hours to 1 year
Locations:
city: Montréal
country: Canada
facility: McGill University health Centre
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Arnold S Kristof, MDCM, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Omiya K, Sato H, Sato T, Wykes L, Hong M, Hatzakorzian R, Kristof AS, Schricker T. Albumin and fibrinogen kinetics in sepsis: a prospective observational study. Crit Care. 2021 Dec 17;25(1):436. doi: 10.1186/s13054-021-03860-7.