Amino Acid Therapy for Acute Kidney Injury

(BRAVE-HEART Trial)

Overseen By Kelli Krallman, RN, BSN, MS

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Stuart Goldstein, MD

Disqualifiers: Chronic kidney disease, Anuria, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 72 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether an amino acid infusion can prevent acute kidney injury in children undergoing heart surgery. It seeks to determine if this treatment not only reduces kidney problems but also decreases the time spent on ventilators post-surgery. Participants will receive either an amino acid infusion or a placebo (a look-alike substance with no active drug) during and after their surgery for up to 72 hours. Children expected to be at high risk for kidney problems after heart surgery are a good fit for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Earlier studies have shown that administering amino acids through an IV is safe. Research suggests these infusions protect the kidneys, particularly in patients undergoing heart surgery. This indicates the treatment might be well-tolerated, as it has been tested in similar contexts.

Although these studies involved adults, they provide a strong basis to expect similar safety in children. The research consistently shows that amino acids can reduce the risk of kidney problems without causing major issues. So far, no strong evidence of serious side effects has emerged. This suggests that the amino acid treatment is likely safe for prospective participants in this clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for acute kidney injury?

Most treatments for acute kidney injury (AKI) focus on managing symptoms and supporting kidney function, like dialysis or medication to control blood pressure and fluid levels. But Amino Acid Infusion is unique because it targets the root cause of kidney damage by potentially enhancing the repair and regeneration of kidney cells. Researchers are excited about this treatment because amino acids are the building blocks of proteins, and they believe infusing them directly could help the kidneys heal faster and more effectively. This approach could offer a new way to address AKI beyond just managing symptoms.

What evidence suggests that an amino acid infusion might be an effective treatment for acute kidney injury?

Research has shown that administering amino acids directly into the bloodstream can protect the kidneys. In earlier studies, patients who received these amino acid infusions during heart surgery experienced fewer sudden kidney problems compared to those who received a placebo, a harmless substance. One study found that amino acids reduced the duration of kidney issues and improved kidney function in the days following surgery. Additionally, these infusions have increased a measure of kidney health called eGFR. Although some past results have varied, the overall evidence suggests that amino acid infusions could benefit kidney protection. Participants in this trial will receive either an Amino Acid Infusion or a Placebo Infusion for up to 72 hours to evaluate their effectiveness in treating acute kidney injury. ^{1 2 3 4 6}

Who Is on the Research Team?

Stuart Goldstein, MD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

The BRAVE-HEART trial is for children undergoing cardiac surgery who are at risk of acute kidney injury. They must be receiving mechanical ventilation post-surgery. There's no specific information on exclusion criteria provided, but typically participants with conditions that could interfere with the study or pose additional risks would not be eligible.

Inclusion Criteria

I am at high risk for kidney problems after heart surgery due to my age, surgery score, and expected bypass time.

I am 18 years old or younger.

I weigh at least 5 kilograms.

Exclusion Criteria

Known hypersensitivity to amino acids

I am receiving support from a machine for an organ outside my body before surgery.

I have a history of chronic kidney disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive an amino acid or placebo infusion for up to 72 hours during cardiac surgery and while in the operating room or intensive care unit

72 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of acute kidney injury and mechanical ventilation needs

4 days

What Are the Treatments Tested in This Trial?

Interventions

• Amino Acid infusion

Trial Overview This study tests if giving an amino acid infusion during and up to 72 hours after cardiac surgery can prevent acute kidney injury in children. It compares the effects of amino acids against a placebo while patients are in the operating room or ICU.

How Is the Trial Designed?

Group I: Acid Acid Infusion Experimental Treatment 1 Intervention

Amino Acid Infusion for up to 72 hours

Group II: Placebo Infusion Placebo Group 1 Intervention

Placebo Infusion for up to 72 hours

Who Is Running the Clinical Trial?

Stuart Goldstein, MD

Lead Sponsor

Congenital Heart Alliance of Cincinnati

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11840255/

Intravenous amino acid for kidney protection - PubMed Central Intravenous amino acid administration, compared to placebo, significantly reduced the occurrence of AKI, providing the first level 1 evidence of an effective ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0883944124004246

Protective effect of intravenous amino acid on kidney function Animal studies have shown that intravenous amino acid therapy improves renal function, but clinical studies report inconsistent results. A number of recent ...

3. nejm.org nejm.org/doi/abs/10.1056/NEJMoa2403769

A Randomized Trial of Intravenous Amino Acids for Kidney ... Among adult patients undergoing cardiac surgery, infusion of amino acids reduced the occurrence of AKI.

4. annalsthoracicsurgery.org annalsthoracicsurgery.org/article/S0003-4975(24)01029-4/fulltext

Intravenous Amino-acid Infusion to Prevent Acute Kidney ... Compared with usual care, IV AAs reduced the mean duration of AKI from 0.45 day to 0.08 days (P = .037) and increased eGFR in the first 6 days ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39447274/

Protective effect of intravenous amino acid on kidney function The results showed that compared with the control group, intravenous amino acid administration significantly reduced the incidence of AKI (RR: ...

6. thebottomline.org.uk thebottomline.org.uk/summaries/icm/protection-amino-acids-for-kidney-protection/

PROTECTION – Amino Acids for Kidney Protection This trial shows that amino acids reduce acute kidney injury following cardiac surgery with cardiopulmonary bypass; However, most of the ...