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

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.

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 Overview

• Status: Recruiting
• Conditions: Cardiac Surgery-associated Acute Kidney Injury
• Intervention / Treatment: Other: No investigational study intervention

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: (+)1-888-84 22937; Email: clinical-trials-contact@bayer.com

Study Locations

• Germany
  • North Rhine-Westphalia
    • Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
      • Recruiting
      • Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)
• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0AY
      • Recruiting
      • Royal Papworth Hospital NHS Foundation Trust | Royal Papworth Hospital - Cardiac Surgery
  • Greater London
    • Harefield, Greater London, United Kingdom, UB9 6JH
      • Not yet recruiting
      • Guy's and St Thomas' NHS Foundation Trust | Harefield Hospital - Cardiology
    • London, Greater London, United Kingdom, SE1 7EH
      • Recruiting
      • Guy's and St Thomas' NHS Foundation Trust | Guy's & St Thomas' Hospital - Department of Critical Care & Nephrology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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, chronic rheumatic heart diseases, acute rheumatic heart pericarditis, endocarditis, myocarditis, rheumatic mitral valve diseases, rheumatic aortic valve diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cardiac surgery; 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.

Other: No investigational study intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with CSA-AKI until Day 3 post-surgery	CSA-AKI: cardiac surgery-associated acute kidney injury	Up to 3 days post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	Up to 7 days post surgery

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: January 8, 2025
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cardiac surgery; Cardiopulmonary bypass; CSA-AKI
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury; Wounds and Injuries
• Other Study ID Numbers: 22785

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No