Not yet recruiting NCT07001098

Amino Acids for Cardiac Surgery Associated AKI

Phase II Interventional Acute Kidney Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Amino Acids, Placebo.
Who it may be relevant to: Registry conditions: Acute Kidney Injury. Basic parameters: 1 Day — 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

Amino Acids for the Infant at Risk for Acute Kidney Injury After Cardiac Surgery: A Pilot Study

The purpose of this study is to assess the feasibility of amino acid infusions in pediatric cardiac surgery patients.

Drug Amino 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
Drug Placebo
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

Number of Participants with Amino acids Related Adverse Events [Time frame: Baseline, Daily during infusion upto 48 hours after completion of infusion (upto 5 days)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 1 center

NCT: NCT07001098 · 80133