Study on Preventing Acute Kidney Injury in Cardiac Surgery Patients Using Dapagliflozin

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What is this study about?

This clinical trial is focused on studying a condition known as Acute Kidney Injury (AKI), which can occur in patients undergoing heart surgery. The trial will explore the effectiveness of a treatment using a medication called Forxiga, which contains the active ingredient dapagliflozin. This medication is typically used in the form of film-coated tablets. The purpose of the study is to see if this treatment can help prevent AKI in patients who are having certain types of heart surgery.

Participants in the study will be given either the medication or a placebo, and their health will be monitored for a period of time after their surgery. The study will look at how often AKI occurs within seven days after surgery, as well as other health outcomes such as changes in kidney function, heart health, and recovery quality. The study will also track any side effects or complications that may arise from the treatment.

Throughout the study, various health measurements will be taken, including blood sugar levels, heart function, and kidney health. The study aims to provide valuable information on whether the medication can effectively protect the kidneys during and after heart surgery, potentially improving recovery and reducing the risk of serious complications. The trial is expected to continue until June 2025.

1 joining the study

Eligibility is confirmed for individuals over 18 years old who are scheduled for elective cardiac surgery with cardio-pulmonary bypass or off-pump coronary artery bypass surgery.

Informed consent is required to participate in the study.

2 medication administration

The medication used in the study is Forxiga 10 mg film-coated tablets, which contains the active substance dapagliflozin.

The tablets are taken orally as part of the study protocol.

3 surgery and monitoring

Participants undergo the planned cardiac surgery.

Monitoring for Acute Kidney Injury (AKI) is conducted for 7 days post-surgery, following the KDIGO criteria.

4 postoperative assessments

Various health parameters are assessed, including kidney function, heart function, and recovery quality.

Specific assessments include changes in estimated Glomerular Filtration Rate (eGFR), occurrence of atrial fibrillation, and length of stay in the Intensive Care Unit and hospital.

5 safety and outcomes evaluation

Safety outcomes such as infections, diabetic keto-acidosis, and hypoglycemia are monitored.

Major adverse events related to kidney and cardiovascular health are evaluated.

6 completion of study

The study is estimated to conclude by June 9, 2025.

Final assessments and data collection are completed to evaluate the effectiveness and safety of the treatment.

Who Can Join the Study?

Must be over 18 years old.
Must be having planned heart surgery. This includes surgery with a machine that helps the heart and lungs work during the operation, known as cardio-pulmonary bypass (CPB), or a type of heart surgery called off-pump coronary artery bypass surgery (OPCAB), which is done without stopping the heart.
Must be able to give informed consent, meaning you understand the study and agree to participate.

Who Cannot Join the Study?

Individuals who have a history of AKI (Acute Kidney Injury), which is a sudden decrease in kidney function.
Participants who are not within the specified age range for the study.
Individuals who belong to a vulnerable population, which means they might need special protection or care.
Participants who do not meet other specific health criteria set by the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Frisius	Heerenveen	The Netherlands
Stichting OLVG	Amsterdam	The Netherlands

Other Sites

Site Name	City	Country
Isala Klinieken Stichting	Zwolle	The Netherlands
Amphia Hospital	Breda	The Netherlands
Medisch Spectrum Twente	Enschede	The Netherlands
Lzmyv Uslokapwxftb Mgolgoh Cochvmc (cpzuu	Leiden	The Netherlands
Atzdqviso Uuc	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	09.06.2023

Trial locations

Investigated drugs:

Dapagliflozin

SGLT-2 Inhibitor is a type of medication used in this trial to help protect the kidneys during heart surgery. It works by blocking a protein in the kidneys, which helps to lower blood sugar levels and may also have protective effects on the kidneys. The goal of using this medication in the trial is to prevent acute kidney injury (AKI) in patients undergoing cardiac surgery.

Acute Kidney Injury (AKI) – Acute Kidney Injury is a sudden episode of kidney failure or damage that happens within a few hours or days. It causes waste products to build up in the blood and makes it hard for the kidneys to maintain the right balance of fluid in the body. AKI can occur due to various reasons, including reduced blood flow to the kidneys, direct damage to the kidneys, or blockage of the urinary tract. The condition can lead to a decrease in urine output, swelling in the legs, ankles, and around the eyes, and fatigue. It is often detected through changes in blood tests that measure kidney function. AKI can progress to more severe kidney damage if not addressed, but it is sometimes reversible with appropriate care.

Trial ID:

2024-515260-31-00

NCT ID:

NCT05590143

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Preventing Acute Kidney Injury in Cardiac Surgery Patients Using Dapagliflozin

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?