Amino Acid Nutrition in the Critically-ill

NCT02865408 | Active Not Recruiting

• 1 other identifier: 4738
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Critical Illness; Inflammation; Malnutrition

Keywords

Amino acids; critically-ill; catabolic; nutrition; anabolic

Outcome Measures

Primary Outcomes (1)

• Whole body protein balance

  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.

  0 and 48 hours

Secondary Outcomes (6)

• Synthesis rates of hepatic secretory proteins (the total plasma protein pool, albumin, fibrinogen in %/d)

  0 and 48 hours

• Biomarker of amino acid restriction or repletion - ELISA (pg/ml)

  0, 12, 24, 36, 48, 72 hours

• Biomarker of amino acid restriction or repletion - mRNA detection (copy number/ml)

  0, 12, 24, 36, 48, 72 hours

• Biomarker of amino acid restriction or repletion - protein levels (fold increase in Western blot band density)

  0, 12, 24, 36, 48, 72 hours

• Metabolic Substrates (micromolar)

  0, 24, 36, 48, 72 hours

Other Outcomes (5)

• ICU length of stay

  72 hours to 1 year

• Hospital length of stay

  72 hours to 1 year

• Ventilator-free days in ICU

  72 hours to 1 year

Study Arms (3)

Group 1: Peptamen 1.5% via enteral only

ACTIVE COMPARATOR

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

Dietary Supplement: Peptamen 1.5% via enteral

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

ACTIVE COMPARATOR

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

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

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.

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

Interventions

Peptamen 1.5% via enteral DIETARY_SUPPLEMENT

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.

Also known as: Enteral feeding with Peptamen 1.5%

Group 1: Peptamen 1.5% via enteral only; Group 2: Prosol 20% IV to 1.75g/kg/day; Group 3: Prosol 20% IV to 2.5g/kg/day

Prosol 20% IV to 1.75g/kg/day DIETARY_SUPPLEMENT

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.

Also known as: Enteral feeding with Peptamen 1.5% plus Prosol 20%

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

Prosol 20% IV to 2.5g/kg/day DIETARY_SUPPLEMENT

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.

Also known as: Enteral feeding with Peptamen 1.5% plus Prosol 20%

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arnold Kristof: lead

Study Sites (1)

McGill University health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (2)

• Kristof AS, Hong M, Boufaied N, Tousson-Abouelazm N, Dandamudi S, Joung KB, Hatzakorzian R, Port M, Campisi G, Piccirillo CA, Fonseca GJ, Ding J, Heyland DK, Labbe DP, Wykes L, Schricker T. Biological responses during high-dose protein nutrition in the critically ill: a randomized controlled trial. Am J Clin Nutr. 2025 Aug;122(2):612-623. doi: 10.1016/j.ajcnut.2025.05.025. Epub 2025 Jun 26.

  PMID: 40617772 DERIVED

• 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.

  PMID: 34920728 DERIVED

MeSH Terms

Conditions

Critical Illness; Inflammation; Malnutrition

Interventions

Peptamen; Enteral Nutrition; Amino Acids

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy; Amino Acids, Peptides, and Proteins

Study Officials

• Arnold S Kristof, MDCM, FRCPC

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 7, 2015
• First Posted: August 12, 2016
• Study Start: March 1, 2017
• Primary Completion: January 28, 2026
• Study Completion: February 28, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)