Medical University Of Vienna
Vienna, Austria
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Study on How Albumin Levels Affect Cefazolin in Heart Disease Patients with Low Albumin Undergoing Cardiac Surgery
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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 effects of two medical conditions, heart disease and hypoalbuminemia, which is a condition where there is a low level of albumin in the blood. The study will explore how these conditions affect the way the body processes a medication called cefazolin, which is commonly used to prevent infections during surgery. Additionally, the study will involve the use of Human Albumin, a protein solution given through an infusion, to see how it influences the levels of cefazolin in the body.
The purpose of the study is to understand how different levels of albumin in the blood can change the way cefazolin works in patients undergoing heart surgery. Participants will be randomly assigned to different groups, where some will receive the albumin infusion and others will not. This will help researchers compare the effects of albumin on cefazolin levels in the body. The study will be conducted in an open-label manner, meaning both the participants and the researchers will know which treatment is being administered.
Throughout the study, participants will receive the treatments intravenously, which means the medication will be delivered directly into the bloodstream through a vein. The study will monitor the concentration of cefazolin in the blood over a period of time to gather data on how the drug is processed in the body. This information will help improve understanding of how to best use cefazolin in patients with heart disease and low albumin levels, potentially leading to better treatment outcomes in the future.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
4 criteria
- Provide written informed consent. This means you agree to participate in the study after being informed about all aspects of it.
- Planned use of cardiopulmonary bypass. This is a machine that takes over the function of the heart and lungs during surgery.
- Be between the ages of 18 and 90 years old.
- Have an ejection fraction greater than 40%. This is a measure of how well your heart is pumping blood.
Who cannot join the trial?
2 criteria
- People with heart disease cannot participate.
- People with hypoalbuminemia cannot participate. Hypoalbuminemia means having low levels of a protein called albumin in the blood.
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Investigated drugs
Cefazolin is an antibiotic used to prevent infections during surgery. In this clinical trial, researchers are studying how the levels of a protein in the blood, called albumin, affect how the body processes this medication. Cefazolin is given to patients undergoing heart surgery to help prevent infections, and the study aims to understand how different levels of albumin might change the way the drug works in the body.
What is already known about the treatment
Cefazolin – Cefazolin is administered through an injection, typically given into a vein or muscle by a healthcare professional. It is currently being studied in the context of heart disease and low levels of albumin in the blood, particularly in patients undergoing cardiac surgery. The main therapeutic use of Cefazolin is to treat bacterial infections by stopping the growth of bacteria. At the molecular level, it works by interfering with the bacteria's cell wall formation, which ultimately leads to the bacteria's death. Cefazolin belongs to a class of drugs known as cephalosporin antibiotics.
Investigated diseases
Heart Disease
Heart disease refers to a range of conditions affecting the heart's structure and function. It often involves narrowed or blocked blood vessels, which can lead to chest pain or heart attacks. Over time, heart disease can cause the heart to weaken, affecting its ability to pump blood efficiently. This can result in symptoms such as shortness of breath, fatigue, and swelling in the legs or abdomen. The progression of heart disease can vary, with some individuals experiencing rapid changes, while others may have a more gradual development of symptoms. Lifestyle factors, such as diet and exercise, can influence the progression of heart disease.
Hypoalbuminemia
Hypoalbuminemia is a condition characterized by low levels of albumin in the blood. Albumin is a protein produced by the liver, and it plays a crucial role in maintaining the osmotic pressure needed for proper distribution of body fluids. When albumin levels drop, fluid can leak out of blood vessels, leading to swelling, particularly in the legs and abdomen. This condition can develop due to various factors, including liver disease, kidney problems, or malnutrition. As hypoalbuminemia progresses, it can affect the body's ability to transport hormones, vitamins, and drugs. The severity and progression depend on the underlying cause and the body's response to it.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518338-10-00Protocol codeALBUCEFEstimated enrolment20 patientsSponsorMedical University Of Vienna
sourced from the EU Clinical Trials Register and site verification
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