Amino Acid Infusion in Cardiac Surgery (NCT07030933) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Amino Acid Infusion in Cardiac Surgery
130 participantsStarted 2026-10-01
Plain-language summary
The goal of this study is to see if an infusion of amino acids given to adult male and female patients during cardiac surgery can help prevent acute kidney injury that commonly occurs when patients undergo cardiac surgery needing cardiopulmonary bypass. The main question the study aims to answer is if a short infusion of amino acids given to study participants during their scheduled heart surgery can decrease rates of acute kidney injury - which will be measured by biological markers of kidney injury in the urine.
The study will be conducted in 2 phases. Participants in the first phase will receive the current standard of anesthetic care for patients having heart surgery and markers of acute kidney injury will be measured before and after their surgery. Participants in the second group will receive the anesthetic standard of care plus a short infusion of amino acids during their surgery. They will also have markers of kidney injury measured before and after their surgery. This study is based on prior studies that showed amino acid infusions are protective against kidney injury; however, these past studies did not look at markers of kidney injury in the urine.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quantification of acute kidney injury biomarker: tissue inhibitor of metalloproteinases 2 (TIMP-2)
Timeframe: In the first hour upon arrival to the ICU, following completion of surgery. On average 6 hours from start of procedure, up to 12 hours.
2
Quantification of acute kidney injury biomarker: insulin-like growth factor-binding protein 7 (IGFBP7)
Timeframe: Baseline prior to cardiopulmonary bypass
3
Quantification of acute kidney injury biomarker: insulin-like growth factor-binding protein 7 (IGFBP7)
Timeframe: In the first hour upon arrival to the ICU, following the completion of surgery. On average 6 hours from the start of the procedure, up to 12 hours.