Cardiac Surgery-associated Acute Kidney InjuryNCT06772025
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
A study testing No investigational study intervention in people with Cardiac Surgery-associated Acute Kidney Injury, run by Bayer at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery-associated Acute Kidney Injury
- What is being tested?
- No investigational study intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 3 Feb 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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, chronic rheumatic heart diseases, acute rheumatic heart pericarditis, endocarditis, myocarditis, rheumatic mitral valve diseases, rheumatic aortic valve diseases
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United Kingdom3 sites, 3 recruiting
- Recruiting
Royal Papworth Hospital | Cardiac Surgery
Cambridge, Cambridgeshire, CB2 0AY
- Recruiting
Harefield Hospital | Cardiology
Harefield, Greater London, UB9 6JH
- Recruiting
St Thomas' Hospital | Critical Care
London, Greater London, SE1 7EH
Germany1 site, 1 recruiting
- Recruiting
Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, North Rhine-Westphalia, 32545
About this study
Official title: Methodology Study in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass to Investigate Mechanisms Involved in Cardiac Surgery-associated Acute Kidney Injury.
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.
Read more
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
- Being tested
- No investigational study intervention
- Keywords
- CSA-AKI, Cardiac surgery, Cardiopulmonary bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No investigational study interventionOther
No investigational study interventions will be administered in this study. Participants will undergo therapeutic and diagnostic procedures as per local standard medical care and as deemed appropriate by the treating physicians. Collection of blood (not exceeding 200 mL) and urine samples and of available clinical data are the only activities performed in addition.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac surgery | Experimental | Patients scheduled for cardiac surgery with cardiopulmonary bypass will be managed according to local standard medical care. Blood and urine will be obtained pre-surgery and post-surgery for analysis. Receives: Other: No investigational study intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with CSA-AKI until Day 3 post-surgery
CSA-AKI: cardiac surgery-associated acute kidney injury
Measured: Up to 3 days post surgery
Secondary outcomes (3)
Observed values of pre-defined biomarkers overall and by CSA-AKI outcome
Non-genetic biomarkers will be investigated from blood, plasma, and urine collected in this study. CSA-AKI: cardiac surgery-associated acute kidney injury
Measured: Up to 7 days post surgery
Change from baseline of pre-defined biomarkers overall and by CSA-AKI outcome
Non-genetic biomarkers will be investigated from blood, plasma, and urine collected in this study. CSA-AKI: cardiac surgery-associated acute kidney injury
Measured: Up to 7 days post surgery
Ratio to baseline of pre-defined biomarkers overall and by CSA-AKI outcome
Non-genetic biomarkers will be investigated from blood, plasma, and urine collected in this study. CSA-AKI: cardiac surgery-associated acute kidney injury
Measured: Up to 7 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start3 Feb 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery-associated Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772025
- Sponsor's protocol ID
- 22785
- Status last verified
- 24 Jul 2026
- First submitted
- 8 Jan 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methodology Study in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass to Investigate Mechanisms Involved in Cardiac Surgery-associated Acute Kidney Injury.
- ClinicalTrials.gov ID
- NCT06772025
- Acronym / sponsor ID
- 22785
- Keywords
- CSA-AKI, Cardiac surgery, Cardiopulmonary bypass
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery | Experimental | Other: No investigational study interventionPatients scheduled for cardiac surgery with cardiopulmonary bypass will be managed according to local standard medical care. Blood and urine will be obtained pre-surgery and post-surgery for analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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):
- Participant with: chronic kidney disease (CKD): 30 ≤ estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m^2
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No investigational study interventionNo investigational study interventions will be administered in this study. Participants will undergo therapeutic and diagnostic procedures as per local standard medical care and as deemed appropriate by the treating physicians. Collection of blood (not exceeding 200 mL) and urine samples and of available clinical data are the only activities performed in addition. | Other | Cardiac surgery |
Primary outcome
Number of participants with CSA-AKI until Day 3 post-surgery
Time frame: Up to 3 days post surgery
CSA-AKI: cardiac surgery-associated acute kidney injury
3 secondary outcomes
Observed values of pre-defined biomarkers overall and by CSA-AKI outcome
Time frame: Up to 7 days post surgery
Change from baseline of pre-defined biomarkers overall and by CSA-AKI outcome
Time frame: Up to 7 days post surgery
Ratio to baseline of pre-defined biomarkers overall and by CSA-AKI outcome
Time frame: Up to 7 days post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No investigational study intervention in people with Cardiac Surgery-associated Acute Kidney Injury, run by Bayer at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bayer Clinical Trials Contact (18888422937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with CSA-AKI until Day 3 post-surgery (time frame: Up to 3 days post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.