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Study on L-Glutamic Acid and Sodium Chloride to Prevent Acute Kidney Injury in High-Risk Heart Surgery Patients Without Diabetes

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the prevention of Acute Kidney Injury (AKI) and heart failure in patients undergoing coronary artery bypass surgery (CABG) who do not have diabetes. The treatment being tested is an infusion of L-Glutamic Acid, a chemical that is administered through a vein. The study will also use a placebo for comparison. The main goal is to determine if L-Glutamic Acid can effectively prevent AKI after surgery in patients who are considered high-risk.

Participants in the study will receive either the L-Glutamic Acid infusion or a placebo during their surgery. The study will monitor the patients for any increase in a substance called p-creatinine, which is a marker used to detect AKI. Additionally, the study will observe changes in another marker, p-NT-proBNP, which is related to heart function, from the day before surgery to the third day after surgery.

The trial is expected to start recruiting participants in March 2025 and aims to conclude by June 2027. The study is designed to provide valuable insights into whether L-Glutamic Acid can help reduce the risk of kidney injury and heart complications in patients undergoing heart surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria. This includes being an adult without diabetes, undergoing heart surgery with a heart-lung machine, and having certain risk factors related to heart conditions.
Step 2
Pre-surgery preparation
Before the surgery, baseline measurements are taken. This includes checking kidney function through a blood test to measure p-creatinine levels.
Step 3
Surgery and medication administration
During the coronary artery bypass surgery, an intravenous infusion of l-glutamic acid is administered. This is done to help prevent acute kidney injury, a potential complication after surgery.
Step 4
Post-surgery monitoring
After the surgery, kidney function is monitored by measuring p-creatinine levels. A significant increase in these levels may indicate acute kidney injury.
Additionally, p-NT-proBNP levels are measured from the day before surgery to the third day after surgery to assess heart function.
Step 5
Follow-up and conclusion
The study continues to monitor the patient's recovery and any changes in kidney or heart function. The trial aims to conclude by June 2027, with ongoing assessments to ensure patient safety and gather data on the effectiveness of the treatment.

Who can join the trial?

10 criteria

Must be an adult patient.
Must not have diabetes.
Must have undergone heart surgery using a machine that takes over the function of the heart and lungs during the operation.
Must have had coronary artery bypass surgery (CABG) involving at least two blocked blood vessels or a blockage in the main artery of the heart.
May have had an additional procedure during the heart surgery.
Must have a EuroSCORE II of 3.0 or higher. EuroSCORE II is a system used to predict the risk of death after heart surgery.
Must have at least one heart-related or surgery-related risk factor contributing to the EuroSCORE II.
Must have a Left Ventricular Ejection Fraction of 0.30 or less. This is a measure of how well the heart pumps blood with each beat.
Both male and female patients are eligible.
Patients considered vulnerable are not included.

Who cannot join the trial?

5 criteria

Patients with diabetes cannot participate. Diabetes is a condition where the body has trouble managing blood sugar levels.
Patients who are not considered high-risk for acute kidney injury (AKI) after surgery cannot participate. AKI is a sudden decrease in kidney function.
Patients who have not undergone coronary artery bypass surgery (CABG) cannot participate. This surgery helps improve blood flow to the heart.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations may include groups like children or pregnant women.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
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Gothenburg, Sweden
Region Oestergoetland
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Linkoping, Sweden
Region Skane Skanes Universitetssjukhus
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Lund, Sweden

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Investigated drugs

Glutamate Infusion is being studied to see if it can help prevent acute kidney injury in patients undergoing coronary artery bypass surgery. This therapy involves giving patients an infusion of glutamate, which is a substance that might help protect the kidneys during surgery. The goal is to see if this treatment can reduce the risk of kidney problems after the surgery, especially in patients who are considered high-risk but do not have diabetes.

What is already known about the treatment

Glutamate – Glutamate is administered intravenously, meaning it is given directly into a vein through an infusion. It is currently being studied in clinical trials to assess its effectiveness in preventing acute kidney injury and heart failure following coronary artery bypass surgery in patients who do not have diabetes. The main therapeutic indication for glutamate in this context is to protect kidney function and support heart health during and after surgery. At the molecular level, glutamate acts as a key neurotransmitter in the brain and plays a role in cellular metabolism, potentially helping to improve energy production and reduce oxidative stress in tissues. It is classified pharmacologically as an amino acid and neurotransmitter.

Investigated diseases

Acute Kidney Injury
This condition involves a sudden decrease in kidney function, leading to the accumulation of waste products in the blood. It often occurs after major surgeries, such as coronary artery bypass surgery, especially in high-risk patients. The kidneys may struggle to filter blood effectively, resulting in increased levels of creatinine. This condition can develop quickly, sometimes within a few hours or days. It may cause symptoms like reduced urine output, swelling, and fatigue. The progression can vary, with some cases resolving quickly while others may lead to more prolonged kidney issues.
Heart Failure
This condition occurs when the heart is unable to pump blood effectively, leading to insufficient blood flow to meet the body's needs. It can develop after coronary artery bypass surgery due to stress on the heart. Symptoms may include shortness of breath, fatigue, and fluid retention, which can cause swelling in the legs and abdomen. The heart may become enlarged or weakened, affecting its ability to function properly. Over time, the condition can worsen, leading to more severe symptoms. The progression can vary, with some individuals experiencing stable periods and others facing more rapid changes.