Improving nutrition for critically ill patients using amino acids
Enhancing the Anabolic Effect of Nutrition in Critically Ill Patients by Administering Exogenous Amino Acids
This study is testing if giving extra amino acids through an IV can help critically ill patients in the ICU get better nutrition and improve their recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 1 site (Montréal, Quebec) |
| Trial ID | NCT02865408 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the anabolic effects of nutrition in critically ill patients by administering exogenous amino acids. It focuses on patients in the intensive care unit who are often catabolic and undernourished. The researchers will provide intravenous amino acids to restore anabolic processes and assess the impact on clinical outcomes and molecular markers of protein synthesis. The findings will help establish biomarkers of nutritional success for future clinical trials involving amino acid supplementation.
Who should consider this trial
Good fit: Ideal candidates include mechanically ventilated adult patients over 18 years old who are expected to require ICU care for at least three additional days.
Not a fit: Patients who are moribund or expected to have life-sustaining treatments withdrawn within three days will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes for critically ill patients by enhancing their nutritional status.
How similar studies have performed: Previous observational studies have suggested that increased protein or essential amino acid intake may improve clinical outcomes in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion 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Criteria: * Patients who are moribund (expected death within 48 hours) * Expected to have life-sustaining treatments withdrawn in the next 3 days * Those with a contraindication to enteral nutrition (EN) * Already on parenteral nutrition (PN) * Those with acute fulminant hepatitis or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.
Where this trial is running
Montréal, Quebec
- McGill University health Centre — Montréal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Arnold S Kristof, MDCM, FRCPC — McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study coordinator: Arnold S Kristof, MDCM, FRCPC
- Email: arnold.kristof@mcgill.ca
- Phone: 501-934-1934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.