Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2025-12-24 @ 1:42 PM
NCT ID:
NCT07212595
Eligibility Criteria:
Inclusion Criteria:
* Expected to be at high risk of developing acute kidney injury after cardiac surgery based on Age, The Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery (STAT) score, and anticipated cardiopulmonary bypass time
* Age less than or equal to 18 years
* Weight greater than or equal to 5 kilograms
Exclusion Criteria:
* Preoperative extracorporeal organ support
* History of chronic kidney disease
* Known or suspected inborn errors of amino acid metabolism
* Known hypersensitivity to amino acids
* Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) \> 3 times the upper limit of normal for age/gender
* Preterm infants less than 6 months of age who were born at less than 36 weeks gestational age
* Anuria at the time of randomization
* Expected use of total parental nutrition (TPN) within the first 72 hours post-operatively
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT07212595
Study Brief:
Protocol Section:
NCT07212595