Acute Kidney Injury
Conditions
Keywords
cardiac surgery
Brief summary
The purpose of this study is to assess the feasibility of amino acid infusions in pediatric cardiac surgery patients.
Interventions
DRUGAmino Acids
The participants receive a continuous infusion of a balanced mixture of amino acids (Trophamine) in a dose of 2g/kg/day (max 100g/day) starting at the time of cardiac surgery up to 3 days
DRUGPlacebo
The participants receive a continuous infusion of a lactated ringers (placebo), equivalent volume to amino acids, starting at the time of cardiac surgery up to 3 days
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No
Inclusion criteria
* Undergoing cardiac surgery and expected to be high risk
Exclusion criteria
* preoperative extracorporeal organ support * CKD history (GFR\<60ml/min/1.73m2 \[≤1year\] and GFR\<90ml/min/1.73m2 \[\>1 year\]) * serum creatinine defined preoperative AKI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Amino acids Related Adverse Events | Baseline, Daily during infusion upto 48 hours after completion of infusion (upto 5 days) |
Countries
United States
Outcome results
None listed