Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
30 participants
INTERVENTIONAL
2017-03-01
2026-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of an Amino Acid Blend on Muscle and Gut Functionality in ICU Patients
NCT02968836
Effect of Combined IV Bolus Amino Acid Supplementation and Mobilisation on Skeletal Muscle During the First 10 Days in the ICU: A RCT
NCT04099108
Effect of Amino Acid on Muscle Damage
NCT03319147
Development of Oral Amino Acid Tracers to Study Protein Turnover in Humans
NCT04887727
Local Effects of Amino Acids and 3-hydroxybutyrate in the Bilaterally Perfused Human Leg
NCT01461603
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1: Peptamen 1.5% via enteral only
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
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.
Group 2: Prosol 20% IV to 1.75g/kg/day
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
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.
Group 3: 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/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 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Vasopressor therapy, or mechanical circulatory support) at the point of screening of an additional 3 days, as estimated by the treating physician.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Arnold Kristof
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Arnold Kristof
Doctor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Arnold S Kristof, MDCM, FRCPC
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
McGill University health Centre
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
4738
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.