What this study is
The purpose of this study is to assess the feasibility of amino acid infusions in pediatric cardiac surgery patients.
What's being tested
- Amino Acids
Intervention · DRUG
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
- Placebo
Intervention · DRUG
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
Study details
- Official title
- Amino Acids for the Infant at Risk for Acute Kidney Injury After Cardiac Surgery: A Pilot Study
- Sponsor
- Stanford University
- Conditions
- Acute Kidney Injury
- Enrolling
- 30 people
- Starts
- 2025-09
- Est. completion
- 2026-11
- Design
- Quadruple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 1 Day – 18 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Undergoing cardiac surgery and expected to be high risk
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openLucile Packard Children's Hospital
Palo Alto, California, United States
Study team
Sponsor
Stanford University
Study ID 80133
Principal investigator
Shina Menon, MD
Stanford University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.