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:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-25 @ 2:58 AM
NCT ID:
NCT07030933
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients 18 years of age or older undergoing elective cardiac surgery requiring cardiopulmonary bypass.
* Anticipated stay of at least one night in the ICU following cardiac surgery.
* Eligible patients must have a baseline serum creatinine measurement obtained during the current hospitalization, or within 365 days of the current hospitalization.
* Patients agree to participation and completed informed consent process.
Exclusion Criteria:
* Preoperative or planned post-operative need for renal replacement therapy.
* Stage IV or greater chronic kidney disease, defined as estimated glomular filtration rate of less than 30 mL/minute per 1.73 M\^2 of body surface area as calculated by the Cockcroft-Gault equation.
* Emergent cardiac surgical patients and patients undergoing orthotopic heart transplant.
* Any patient who has a history of renal transplant.
* Patients who have a documented allergy or hypersensitivity to one or more of the amino acids.
* Patients with cognitive impairment who cannot provide consent.
* Patients with congenital alteration of amino acid metabolism.
* Any patient who declines to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07030933
Study Brief:
Protocol Section:
NCT07030933