Amino Acid Nutrition in the Critically-ill (AA-ICU)

Arnold Kristof

Status: Enrolling

Conditions: Inflammation; Malnutrition; Critical Illness

Treatments: Dietary Supplement: Prosol 20% IV to 2.5g/kg/day; Dietary Supplement: Prosol 20% IV to 1.75g/kg/day; Dietary Supplement: Peptamen 1.5% via enteral

Study type: Interventional

Funder types: Other

Identifiers

NCT02865408

4738

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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• Expected to have life-sustaining treatments withdrawn in the next 3 days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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Group 1: Peptamen 1.5% via enteral only

Active Comparator group

Description:

Study patients in this group will be prescribed 1.0 g/kg/d of protein using standard EN 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

Treatment:

Dietary Supplement: Peptamen 1.5% via enteral

Group 2: Prosol 20% IV to 1.75g/kg/day

Active Comparator group

Description:

Patients in group 2 will receive the same enteral feeding as group 1 (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/d

Treatment:

Dietary Supplement: Peptamen 1.5% via enteral

Dietary Supplement: Prosol 20% IV to 1.75g/kg/day

Group 3: Prosol 20% IV to 2.5g/kg/day

Active Comparator group

Description:

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/day.

Treatment:

Dietary Supplement: Peptamen 1.5% via enteral

Dietary Supplement: Prosol 20% IV to 2.5g/kg/day