NCT06772025

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cardiac Surgery-associated Acute Kidney Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-03
• Primary completion: 2027-01-31
• Completion: 2027-01-31
• First posted: 2025-01-13
• Last updated: 2026-03-31

Locations

4 sites across 2 countries: Germany, United Kingdom