NCT02865408

Amino Acid Nutrition in the Critically-ill

Enhancing the Anabolic Effect of Nutrition in Critically Ill Patients by Administering Exogenous Amino Acids

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Arnold Kristof · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Critical Illness
• Inflammation
• Malnutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2017-03-01
• Primary completion: 2026-01-28
• Completion: 2026-02-28
• First posted: 2016-08-12
• Last updated: 2025-10-06

Locations

1 site across 1 country: Canada