30 Participants Needed

Amino Acid Nutrition for Critical Illness

(AA-ICU Trial)

AS
JC
Overseen ByJosie Campisi, RN, CRC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the idea that Amino Acid Nutrition for Critical Illness is an effective treatment?

The available research does not provide any data specifically supporting the effectiveness of Amino Acid Nutrition for Critical Illness. The studies mentioned focus on other treatments and drugs, such as antibiotics and their dosing in critically ill children, rather than on Amino Acid Nutrition.12345

What safety data exists for amino acid nutrition in critical illness?

The safety data for amino acid nutrition in critical illness is limited. Some studies have reported severe side effects with parenteral nutrition containing amino acids, fat emulsion, and glucose. However, these studies primarily focus on the lipid component rather than amino acids specifically. Alternative lipid emulsions, such as olive oil-based formulations, have shown a better safety profile compared to soybean oil-based emulsions, but further research is needed to determine the safety of amino acid components in these formulations.678910

Is Peptamen 1.5%, Prosol 20% IV a promising treatment for critical illness?

Yes, Peptamen 1.5%, Prosol 20% IV is a promising treatment for critical illness because it provides essential amino acids that help improve protein synthesis and energy supply, which are crucial for recovery in critically ill patients.1112131415

What is the purpose of this trial?

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

Research Team

AS

Arnold S Kristof, MDCM, FRCPC

Principal Investigator

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

Eligibility Criteria

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.

Inclusion Criteria

I am an adult on a ventilator in the ICU and expected to need it or other intensive care for at least 3 more days.

Exclusion Criteria

I have a connection between my lung and chest wall.
I am not on dialysis or ECMO because they affect how my body handles proteins.
Patients who are moribund (expected death within 48 hours)
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive intravenous amino acids and enteral feeding to assess protein metabolism and anabolic processes

48 hours
Continuous monitoring in ICU

Follow-up

Participants are monitored for safety, effectiveness, and secondary outcomes such as mortality and hospital-acquired infections

72 hours to 1 year

Treatment Details

Interventions

  • Peptamen 1.5%
  • Prosol 20% IV
Trial Overview 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.
Participant Groups
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

Peptamen 1.5% is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Peptamen 1.5 for:
  • Malabsorption
  • Short bowel syndrome
  • Chronic diarrhea
  • Cystic fibrosis
  • Malnutrition
  • Cerebral palsy
  • Crohn's disease
🇪🇺
Approved in European Union as Peptamen 1.5 for:
  • Impaired GI function
  • Malabsorption
  • Short bowel syndrome
  • Chronic diarrhea
  • Cystic fibrosis
  • Malnutrition
  • Cerebral palsy
  • Crohn's disease

Find a Clinic Near You

Who Is Running the Clinical Trial?

Arnold Kristof

Lead Sponsor

Trials
1
Recruited
30+

Findings from Research

Using an individualized pharmacokinetic algorithm for protamine dosing after cardiopulmonary bypass resulted in a significantly lower protamine requirement compared to a fixed-dose model, with patients needing an average of 243 mg versus 305 mg (p<0.001).
The algorithm did not negatively impact clotting times or transfusion requirements, suggesting it is a safe and effective alternative to traditional dosing methods.
Pilot validation of an individualised pharmacokinetic algorithm for protamine dosing after systemic heparinisation for cardiopulmonary bypass.Miles, LF., Marchiori, P., Falter, F.[2018]
Continuous infusion (CI) of beta-lactam antibiotics in critically ill children resulted in a higher likelihood of achieving optimal pharmacokinetic exposure compared to intermittent infusion (II), with 69% of CI patients meeting the target versus 47% of II patients.
While CI improved the chances of optimal exposure, it also increased the risk of overexposure, highlighting the need for regular therapeutic drug monitoring in these patients to ensure safety and efficacy.
Beta-lactam exposure and safety in intermittent or continuous infusion in critically ill children: an observational monocenter study.Debray, A., Callot, D., Hirt, D., et al.[2023]
In a study of 28 critically ill children receiving continuous vancomycin infusion, the current dosing scheme was found to be inadequate, leading to underexposure in many patients, with 25% exceeding the recommended area under the curve for effective treatment.
The use of pharmacokinetic models to adjust initial dosing based on individual patient factors like age and weight could improve vancomycin therapy effectiveness, aiming for better target attainment in plasma concentrations.
Achievement of Therapeutic Vancomycin Exposure With Continuous Infusion in Critically Ill Children.Genuini, M., Oualha, M., Bouazza, N., et al.[2019]

References

Pilot validation of an individualised pharmacokinetic algorithm for protamine dosing after systemic heparinisation for cardiopulmonary bypass. [2018]
Beta-lactam exposure and safety in intermittent or continuous infusion in critically ill children: an observational monocenter study. [2023]
Achievement of Therapeutic Vancomycin Exposure With Continuous Infusion in Critically Ill Children. [2019]
Optimal Dosing of Meropenem in a Small Cohort of Critically Ill Children Receiving Continuous Renal Replacement Therapy. [2023]
Beta-Lactams Therapeutic Monitoring in Septic Children-What Target Are We Aiming for? A Scoping Review. [2022]
SO,MCT,OO,FO-ILE Is Associated With Better Side Effect Profile Than SO-ILE in Critically Ill Children Receiving Parenteral Nutrition. [2023]
Severe side effects caused by parenteral nutrition therapy with fat emulsion (10%)/amino acids (15)/glucose (20%) injection: 2 case reports. [2022]
A.S.P.E.N. position paper: Clinical role for alternative intravenous fat emulsions. [2015]
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Tolerability and safety of olive oil-based lipid emulsion in critically ill neonates: a blinded randomized trial. [2015]
Protein metabolism and requirements. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Are intravenous amino acid solutions unbalanced? [2005]
13.United Statespubmed.ncbi.nlm.nih.gov
Protein Requirements in the Critically Ill: A Randomized Controlled Trial Using Parenteral Nutrition. [2022]
14.United Statespubmed.ncbi.nlm.nih.gov
Beneficial Effects of Early Enteral Nutrition After Major Rectal Surgery: A Possible Role for Conditionally Essential Amino Acids? Results of a Randomized Clinical Trial. [2017]
Amino acids - Guidelines on Parenteral Nutrition, Chapter 4. [2021]
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