Study on Reducing Acute Kidney Injury After Heart Surgery Using Angiotensin II or Noradrenaline for Patients with Low Blood Pressure

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What is this study about?

This clinical trial is focused on managing Acute Kidney Injury (AKI), a condition where the kidneys suddenly stop working properly, often after heart surgery. The study will compare two treatments: Angiotensin II, a medication that helps regulate blood pressure, and Noradrenaline (also known as norepinephrine), which is commonly used to increase blood pressure in patients with low blood pressure. The purpose of the study is to see if using Angiotensin II can reduce the occurrence of moderate or severe AKI within 72 hours after cardiac surgery.

Participants in the study will receive either Angiotensin II or Noradrenaline through an intravenous infusion, which means the medication will be delivered directly into the bloodstream. The study will last for a maximum of three days, during which the effects of the treatments on kidney function will be closely monitored. The goal is to determine which treatment is more effective in preventing AKI after heart surgery.

The study will also look at other outcomes, such as the rate of death or the need for dialysis within 90 days, and any long-term changes in kidney function. By comparing these two treatments, researchers hope to find a better way to manage blood pressure and protect kidney function in patients undergoing heart surgery.

1 joining the study

Upon joining the study, informed consent is required. This involves understanding the study’s purpose and agreeing to participate.

2 eligibility confirmation

Eligibility is confirmed based on specific criteria: undergoing cardiac surgery with cardiopulmonary bypass, such as coronary artery bypass grafting (CABG) or valve surgery, and having an elevated risk of acute kidney injury (AKI).

3 treatment administration

The study involves the administration of two medications: noradrenaline and angiotensin II. These are given through intravenous infusion, which means they are delivered directly into the bloodstream.

The specific medication and dosage are determined by the study protocol and are administered to manage blood pressure during and after cardiac surgery.

4 monitoring period

Participants are monitored for the occurrence of moderate or severe AKI within 72 hours after surgery. This involves regular assessments of kidney function and overall health.

5 follow-up assessments

Follow-up assessments occur up to 90 days after surgery. These include monitoring for any dialysis needs, changes in kidney function, and overall health status.

Additional assessments may occur between day 90 and 120 to evaluate the development or progression of chronic kidney disease.

6 study completion

The study is estimated to conclude by April 30, 2027. Participants will be informed of the study’s findings and any relevant health information.

Who Can Join the Study?

Must have undergone cardiac surgery using a machine that temporarily takes over the function of the heart and lungs, including surgeries like coronary artery bypass grafting (CABG), valve surgery, or a combination of both.
Must have an elevated risk of acute kidney injury (AKI), which is a sudden decrease in kidney function. This risk is determined by a score of 1.5 or higher based on the following factors:
- Hemoglobin level less than 130 grams per liter, which is a measure of the protein in red blood cells that carries oxygen, scores 2 points.
- Creatinine level greater than 1.1 milligrams per deciliter, which is a waste product in the blood that indicates kidney function, scores 2 points.
- Age over 70 years scores 1.5 points.
- NYHA class 4, which is a classification of heart failure severity, scores 1.5 points.
- Body Mass Index (BMI) over 30, which indicates obesity, scores 1.5 points.
Must be an adult aged 18 years or older.
Must provide written informed consent, which means agreeing to participate in the study after being fully informed about it.

Who Cannot Join the Study?

Patients who have had a recent acute kidney injury. This means a sudden decrease in kidney function.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are considered part of a vulnerable population, which means they might be at higher risk of harm.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Klinikgruppe Dr. Guth GmbH & Co. KG	Karlsburg	Germany
University Hospital Jena KöR	Jena	Germany
Universitaetsmedizin Goettingen	Goettingen	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Deutsches Herzzentrum Muenchen Des Freistaates Bayern Klinik An Der Technischen Universitaet Muenchen	Munich	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Uccjdmczqt Mahykkw Czgwzk Hmbvddcwwzuentxvc	Hamburg	Germany
Ucbrkalbpalxhkdshpupr Eqonb Ahv	Essen	Germany
Uafhavsxbkmayeuqnuypd Akmjilyp	Augsburg	Germany
Utlvavbonzlhoxyhwppqz Mcqitgnb Aph	Munster	Germany
Upmebpnmxgvaswcjuqwld Wwllkhtsk Ajb	Wuerzburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	06.01.2025

Trial locations

Investigated drugs:

Angiotensin II is a medication used in this trial as the primary vasopressor. It helps to manage low blood pressure by narrowing blood vessels, which increases blood pressure. The trial aims to see if using Angiotensin II can reduce the risk of moderate or severe acute kidney injury after cardiac surgery.

Noradrenaline is another medication used in this trial for managing low blood pressure. It works by stimulating certain receptors in the body, which also causes blood vessels to narrow and blood pressure to rise. The trial compares the effects of Noradrenaline with Angiotensin II to determine which is more effective in preventing kidney injury after surgery.

Investigated diseases:

Acute kidney injury

Acute Kidney Injury – This condition occurs when the kidneys suddenly become unable to filter waste products from the blood. As a result, waste can accumulate to dangerous levels, and the blood’s chemical makeup may become unbalanced. Acute kidney injury can develop rapidly, often within a few hours or days. It is most common in people who are already hospitalized, particularly in critically ill patients who need intensive care. The condition can lead to a range of complications, including fluid buildup, chest pain, and muscle weakness. Recovery can vary, with some individuals experiencing a return to normal kidney function, while others may have lasting damage.

Trial ID:

2024-517771-21-00

Protocol code:

UniMs23_0019

NCT ID:

NCT06615102

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Reducing Acute Kidney Injury After Heart Surgery Using Angiotensin II or Noradrenaline for Patients with Low Blood Pressure

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?