Study on Preventing Acute Kidney Injury After Heart Surgery Using Empagliflozin in Patients Undergoing Elective Cardiac Surgery

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What is this study about?

This clinical trial is focused on studying a condition known as cardiac surgery-associated acute kidney injury. This condition can occur in patients who undergo heart surgery and involves damage to the kidneys. The study will explore the effects of a medication called empagliflozin, which is taken as a film-coated tablet. Empagliflozin is a type of drug known as a sodium-glucose cotransporter 2 inhibitor, which is typically used to help control blood sugar levels in people with diabetes.

The purpose of this study is to determine if taking empagliflozin once daily around the time of surgery can reduce the chances of developing acute kidney injury in patients who are having planned heart surgery that involves the use of a heart-lung machine. Some participants in the study will receive empagliflozin, while others will receive a placebo, which looks like the medication but does not contain the active ingredient. This helps researchers understand the true effect of the medication.

Participants in the study will take the medication or placebo for a period of time before and after their surgery. The study will monitor the participants’ kidney function and overall health for up to 90 days following their surgery to see if there is any improvement or change in their condition. The goal is to find out if empagliflozin can help protect the kidneys during and after heart surgery.

1 joining the study

Upon joining the study, eligibility is confirmed. Participants must be at least 18 years old and require elective cardiac surgery with extracorporeal circulation. Understanding the study’s aim and providing written consent is necessary.

2 medication administration

Participants receive a medication called Jardiance, which contains empagliflozin. This is a film-coated tablet taken orally.

The dosage is 10 mg, administered once daily. The medication is given perioperatively, meaning it is taken around the time of surgery.

3 surgery and monitoring

Participants undergo elective cardiac surgery with the use of extracorporeal circulation. Monitoring of kidney function occurs during and after surgery to assess any changes.

4 post-surgery follow-up

For 90 days following surgery, participants are monitored for any decline in kidney function. This includes checking the estimated glomerular filtration rate (eGFR), which measures how well the kidneys are filtering.

The primary goal is to determine if the medication reduces the incidence of acute kidney injury compared to a placebo.

5 study completion

The study is expected to conclude by December 31, 2027. Participants’ health and kidney function are evaluated throughout the study duration to ensure safety and effectiveness of the treatment.

Who Can Join the Study?

Must be 18 years of age or older.
Must be scheduled for elective cardiac surgery. This means a planned heart surgery that is not an emergency.
The surgery must involve extracorporeal circulation (ECC), which is a process where a machine temporarily takes over the function of the heart and lungs during surgery.
Must be able to understand the purpose of the study and agree to participate by signing a document called informed consent. This document explains the study and confirms your willingness to join.
Both men and women can participate.

Who Cannot Join the Study?

Patients who are not undergoing elective cardiac surgery with extracorporeal circulation. This means the surgery is planned in advance and involves using a machine to help circulate blood outside the body during the procedure.
Patients who are not within the specified age range for the study. The age range is typically defined by the study and may exclude very young or very old individuals.
Patients who are part of a vulnerable population. This refers to groups of people who may have additional risks or challenges, such as those with certain disabilities or those who cannot give informed consent.
Patients who have medical conditions or are taking medications that could interfere with the study or the effects of the study drug.
Patients who are pregnant or breastfeeding, as the study may not be safe for them or their babies.
Patients who have a history of allergic reactions to the study drug or similar medications.
Patients who are participating in another clinical trial, as this could affect the results of the study.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hospital Clinico Universitario De Valladolid	Valladolid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	03.02.2025

Trial locations

Investigated drugs:

Empagliflozin is a medication being studied for its potential to prevent acute kidney injury in patients undergoing elective cardiac surgery. It is taken once daily and works by inhibiting a protein in the kidneys called sodium-glucose cotransporter 2 (SGLT2). This action helps to lower blood sugar levels and may have protective effects on the kidneys during surgery.

Investigated diseases:

Acute kidney injury

Cardiac-surgery associated acute kidney injury – This condition occurs when the kidneys suddenly become unable to filter waste products from the blood effectively after cardiac surgery. It is often linked to the use of extracorporeal circulation during the procedure. The injury can lead to a rapid decline in kidney function, causing waste to accumulate in the body. Patients may experience reduced urine output, swelling, and fatigue. The condition can progress quickly, requiring close monitoring and supportive care. It is a common complication in patients undergoing heart surgery, particularly those with pre-existing kidney issues.

Trial ID:

2024-519997-37-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Preventing Acute Kidney Injury After Heart Surgery Using Empagliflozin in Patients Undergoing Elective Cardiac Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?