At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- No investigational study intervention (other)
- How long the study runs
- Study runs about 23 months (dates as stated)
- About the drug or intervention
- No investigational study intervention — other: No investigational study interventions will be administered in this study.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by Bayer, looks at how acute kidney injury (a sudden drop in how well the kidneys work) develops in people who have heart surgery using a heart-lung machine. It focuses on people having valve surgery, aorta surgery, or at least three coronary artery bypass grafts.
Who can take part
- Adults aged 18 or over who agree to take part
- Having planned heart surgery with a heart-lung machine, such as heart valve surgery (aortic, mitral or tricuspid), aorta surgery, or three or more coronary artery bypass grafts
- Having long-term (chronic) kidney disease with a kidney filtration rate (eGFR) between 30 and less than 90 mL/min/1.73 m²
Who may not be able to
- Emergency surgery
- Anaemia (low red blood cells) with haemoglobin below 10 g/dL
- Signs of infection or an infection needing treatment (a single preventive dose is allowed)
- Treatment that suppresses or calms the immune system, including steroid medicine above 10 mg prednisolone per day
- Cancer treatment in the past 3 months
- Major surgery in the past 2 months
- Acute kidney injury in the past month
- Previous kidney transplant or kidney replacement treatment (such as dialysis)
- Planned use of contrast dye (used in some scans) within 5 days before surgery or during surgery
- Taking part in another trial testing a medicine
- Any reason the research team believes makes taking part unwise
- Certain autoimmune conditions, such as anti-GBM disease, lupus, rheumatic heart disease, inflammation of the heart lining or heart muscle, or rheumatic valve disease
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 200
- Started
- 2025-02-03
- Last checked
- 2026-07-24
Plain English Summary
What is this study?
- • Testing a new treatment for cardiac surgery-associated acute kidney injury
- • NA - 200 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with cardiac surgery-associated acute kidney injury
Where?
- • Cambridge - Royal Papworth Hospital | Cardiac Surgery
- • Harefield - Harefield Hospital | Cardiology
- • London - St Thomas' Hospital | Critical Care
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Participant must be at least 18 years of age at the time of signing the agreement to take part form (ICF).
- ✓Participants who are scheduled for hospital admission for any of the following cardiovascular surgery interventions,...
- ✓Aortic, mitral, or tricuspid valve surgery (repair or replacement)
- ✓Aortic surgery
- ✓≥3 coronary artery bypass grafts
Who cannot take part
- ✗Emergency surgery situation
- ✗Anemia - red blood cell level \<10 g/dL
- ✗Clinical signs of systemic infection or other infection requiring anti-infective treatment (viral, bacterial,...
- ✗Systemic immunosuppressive or anti-inflammatory treatment including corticosteroids \>10 mg prednisolone equivalent/day
- ✗Any anti-cancer treatment within 3 months (e.g. treatment that helps your immune system fight cancer, drug treatment, radiotherapy)
See the full criteria
Where Is This Study? (3 UK sites)
Royal Papworth Hospital | Cardiac Surgery
Cambridge CB2 0AY, United Kingdom
Harefield Hospital | Cardiology
Harefield UB9 6JH, United Kingdom
St Thomas' Hospital | Critical Care
London SE1 7EH, United Kingdom
How to Get in Touch
Bayer Clinical Trials Contact
Sponsor contactCONTACT