Recruiting

Biomarkers for Acute Kidney Injury in Cardiac Surgery Patients

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What is being tested

No investigational study intervention

Other
Who is being recruted

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: February 2025
See protocol details

Summary

Principal SponsorBayer
Study ContactBayer Clinical Trials Contact
Last updated: February 3, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 3, 2025

Actual date on which the first participant was enrolled.

Researchers aim to gain a deeper understanding of acute kidney injury that occurs after heart surgery, known as cardiac surgery-associated acute kidney injury (CSA-AKI). This condition is common among people who undergo heart surgeries, particularly affecting those who are older or have existing conditions like kidney disease or diabetes. The study focuses on identifying biological markers, or biomarkers, which are signs that can indicate how CSA-AKI develops, particularly in the crucial hours and days following surgery. By comparing these biomarkers in patients who do develop CSA-AKI with those who don't, researchers hope to pinpoint potential targets for preventing this complication in the future. Participants in this study are individuals scheduled for heart surgery who are at risk of developing CSA-AKI. They will not receive any experimental treatment as part of the study; instead, they will undergo their planned surgeries as usual. Researchers will collect blood and urine samples from participants before and after their surgeries. They will also review the participants' medical records and test results during their hospital stay. The study lasts up to two months, during which the health of the participants will be closely monitored to gather valuable data on the development of CSA-AKI.

Official TitleMethodology Study in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass to Investigate Mechanisms Involved in Cardiac Surgery-associated Acute Kidney Injury.
Principal SponsorBayer
Study ContactBayer Clinical Trials Contact
Last updated: February 3, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

8 exclusion criteria prevent from participating
Clinical signs of systemic infection or other infection requiring anti-infective treatment (viral, bacterial, fungal, parasitic; single-dose prophylaxis allowed)

Major surgery within 2 months

AKI within the last month

Prior renal transplants or RRT

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Recruiting

Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)

Bad Oeynhausen, GermanyOpen Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW) in Google Maps
Recruiting

Guy's and St Thomas' NHS Foundation Trust | Guy's & St Thomas' Hospital - Department of Critical Care & Nephrology

London, United Kingdom
Recruiting soon

Royal Papworth Hospital NHS Foundation Trust | Royal Papworth Hospital - Cardiac Surgery

Cambridge, United Kingdom
Recruiting soon

Guy's and St Thomas' NHS Foundation Trust | Harefield Hospital - Cardiology

Harefield, United Kingdom
Recruiting
4 Study Centers