A Study to Understand How Cardiac Surgery-associated Acute Kidney Injury Develops in Participants… (NCT06772025) | Clinical Trial Compass
RecruitingNot Applicable
A Study to Understand How Cardiac Surgery-associated Acute Kidney Injury Develops in Participants Who Undergo Heart Surgery With the Use of Heart-lung Machine
Germany, United Kingdom200 participantsStarted 2025-02-03
Plain-language summary
Researchers are looking for a better way to treat and prevent cardiac surgery-associated acute kidney injury (CSA-AKI) in people who undergo heart surgeries.
CSA-AKI is a common complication in people undergoing heart surgeries, where the kidneys stop working properly. CSA-AKI risk factors include older age and alongside diseases such as kidney disease and diabetes. Longer time with heart-lung machine during heart surgeries also increases the occurrence of CSA-AKI.
In this study, researchers want to better understand how CSA-AKI develops (also known as the mechanisms involved in the development of CSA-AKI) in people under heart surgeries, the presence of certain biomarkers in the body, especially with a focus on the early hours and days after the surgery. (A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease.) These biomarkers will be compared in participants who develop CSA-AKI within a week after heart surgery with the participants who do not develop CSA-AKI. The relationship with biomarkers will be determined by examining participants' blood and urine samples before and after surgery.
This may help researchers better understand CSA-AKI, identify potential treatment targets and develop possible treatments to prevent CSA-AKI.
Participants in this study will be people who have heart surgery already scheduled by their own doctors and have a risk of developing CSA-AKI. Participants will not receive any treatment as part of this study. They will undergo the heart surgery and related medical processes as per their normal medical treatment and management.
Each participant will be in the study for up to 2 months. During the study, the doctors and their study team will:
* collect participants' blood and urine samples before and after surgery
* assess participants' medical records and test reports during hospitalization
* monitor overall health of the participants throughout the study
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:
* Participant must be at least 18 years of age at the time of signing the informed consent form (ICF).
* Participants who are scheduled for hospital admission for any of the following cardiovascular surgery interventions, alone or in combination, involving cardiopulmonary bypass (CPB):
* Aortic, mitral, or tricuspid valve surgery (repair or replacement)
* Aortic surgery
* ≥3 coronary artery bypass grafts
* Participant with: chronic kidney disease (CKD): 30 ≤ estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73 m\^2
Exclusion Criteria:
* Emergency surgery situation
* Anemia - hemoglobin \<10 g/dL
* Clinical signs of systemic infection or other infection requiring anti-infective treatment (viral, bacterial, fungal, parasitic; single-dose prophylaxis allowed)
* Systemic immunosuppressive or anti-inflammatory treatment including corticosteroids \>10 mg prednisolone equivalent/day
* Any anti-cancer treatment within 3 months (e.g. immunotherapy, chemotherapy, radiotherapy)
* Major surgery within 2 months
* AKI within the last month
* Prior renal transplants or RRT
* Planned use of contrast media within 5 days prior to surgery or during surgery
* Patient included in an interventional clinical trial involving a pharmacological intervention
* Any reason that would make participation unadvisable, at the discretion of the investigator.
* Autoimmune disorders such as anti-glomerular basement membrane (anti-GBM) diseases, systemic lupus erythematosus…
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
Number of participants with CSA-AKI until Day 3 post-surgery