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Amino Acid Supplement

Group 2: Prosol 20% IV to 1.75g/kg/day for Critical Illness (AA-ICU Trial)

N/A
Recruiting
Led By Arnold S Kristof, MDCM, FRCPC
Research Sponsored by Arnold Kristof
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours to 1 year
Awards & highlights

AA-ICU Trial Summary

This trial is testing whether giving extra amino acids to critically ill patients will help them heal better.

Who is the study for?
This trial is for adults over 18 who are critically ill, on mechanical ventilation in the ICU, and expected to need intensive care for at least three more days. It's not suitable for those with conditions that might interfere with the study or pose extra risks.Check my eligibility
What is being tested?
The study tests if giving extra amino acids through Peptamen (a nutrient mix) via a feeding tube or Prosol IV can help build up body proteins in critically ill patients better than standard care.See study design
What are the potential side effects?
Possible side effects may include digestive discomfort from enteral nutrition and reactions to IV nutrition such as infections, liver problems, or imbalances in blood electrolytes.

AA-ICU Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Whole body protein balance
Secondary outcome measures
Biomarker of amino acid restriction or repletion - ELISA (pg/ml)
Biomarker of amino acid restriction or repletion - mRNA detection (copy number/ml)
Biomarker of amino acid restriction or repletion - protein levels (fold increase in Western blot band density)
+3 more
Other outcome measures
Hospital length of stay
Hospital-acquired infections.
ICU length of stay
+2 more

AA-ICU Trial Design

3Treatment groups
Active Control
Group I: Group 2: Prosol 20% IV to 1.75g/kg/dayActive Control2 Interventions
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
Group II: Group 3: Prosol 20% IV to 2.5g/kg/dayActive Control2 Interventions
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.
Group III: Group 1: Peptamen 1.5% via enteral onlyActive Control1 Intervention
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

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Who is running the clinical trial?

Arnold KristofLead Sponsor
Arnold S Kristof, MDCM, FRCPCPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre
~0 spots leftby Jun 2024
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