Study on How Albumin Levels Affect Cefazolin in Heart Disease Patients with Low Albumin Undergoing Cardiac Surgery

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What is this study about?

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.

1 joining the study

Upon joining the study, you will be required to provide written informed consent. This means you agree to participate after understanding the study’s purpose and procedures.

You must be between the ages of 18 and 90, have a planned use of cardiopulmonary bypass during surgery, and an ejection fraction greater than 40%, which is a measure of how well your heart is pumping.

2 randomization

You will be randomly assigned to one of two groups: the control group or the intervention group. This is done to compare the effects of the treatments being studied.

3 treatment administration

If you are in the intervention group, you will receive an infusion of Human Albumin at a concentration of 20%. This is a solution given through a vein (intravenous).

Both groups will receive Cefazolin, a type of antibiotic, administered intravenously. The dosage is 2 grams, prepared as a solution for injection or infusion.

4 monitoring and data collection

Your blood will be monitored to measure the area under the concentration-time curve (AUC) from 0 to 10 hours. This helps to understand how the drug is processed in your body.

This monitoring will occur over a specified period to gather data on both the free and total drug levels in your system.

5 completion of study participation

Once the monitoring period is complete, your participation in the study will end. The data collected will be used to analyze the effects of albumin levels on the pharmacokinetics of cefazolin.

Who Can Join the Study?

  • 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 Study?

  • People with heart disease cannot participate.
  • People with hypoalbuminemia cannot participate. Hypoalbuminemia means having low levels of a protein called albumin in the blood.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name City Country Status
Medical University Of Vienna Vienna Austria

Other Sites

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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
21.10.2024

Trial locations

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.

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 ID:
2024-518338-10-00
Protocol code:
ALBUCEF
Trial Phase:
Therapeutic confirmatory (Phase III)

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