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RECRUITING
NCT06772025
NA

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

Sponsor: Bayer

View on ClinicalTrials.gov

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

Official title: Methodology Study in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass to Investigate Mechanisms Involved in Cardiac Surgery-associated Acute Kidney Injury.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-02-03

Completion Date

2027-01-31

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

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.

Locations (4)

Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)

Bad Oeynhausen, North Rhine-Westphalia, Germany

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

Cambridge, Cambridgeshire, United Kingdom

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

Harefield, Greater London, United Kingdom

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

London, Greater London, United Kingdom