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

Official title

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

Overview

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

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.

Primary outcome measures

• Number of participants with CSA-AKI until Day 3 post-surgery [Time frame: Up to 3 days post surgery]

Secondary outcome measures (3)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

United Kingdom · 3 centers

• Royal Papworth Hospital NHS Foundation Trust | Royal Papworth Hospital - Cardiac Surgery — Cambridge
• Guy's and St Thomas' NHS Foundation Trust | Harefield Hospital - Cardiology — Harefield
• Guy's and St Thomas' NHS Foundation Trust | Guy's & St Thomas' Hospital - Department of Cr — London

Germany · 1 center

• Herz- und Diabeteszentrum Nordrhein-Westfalen — Bad Oeynhausen

Identifiers

NCT: NCT06772025 · 22785

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗