Pulsatile Blood Flow for Reducing Acute Kidney Injury

Overseen By Nathan J Clendenen, MD,MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Vasoactive medications

Disqualifiers: Sepsis, Delirium, Hemodynamic instability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Intra-operative period, up to 12 hours

1100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether pulsatile blood flow, which mimics the heart's natural pulsing, can reduce the risk of acute kidney injury during heart surgery. Researchers aim to determine if this method is safer and more effective than the usual non-pulsatile flow, which is steady and unvarying. Suitable participants are those scheduled for elective heart surgery requiring a heart-lung machine. As an unphased trial, this study allows participants to contribute to innovative research that could enhance surgical outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on vasoactive medications (drugs that affect blood pressure), you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using pulsatile blood flow during heart-lung machine surgeries is generally safe. It can enhance kidney function and blood circulation during these operations. Studies have found that patients receiving pulsatile blood flow had a lower risk of sudden kidney problems after surgery compared to those who did not, with the risk being about half. This suggests that pulsatile flow might be well-tolerated by patients undergoing this type of procedure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how pulsatile blood flow during cardiopulmonary bypass might reduce acute kidney injury. Unlike standard practices that use non-pulsatile blood flow, this method mimics the natural heartbeat's rhythm, potentially offering better protection for the kidneys. The hope is that by using a more natural flow pattern, organs can receive improved oxygen and nutrient delivery during surgery, reducing the risk of injury. This could lead to better outcomes for patients undergoing procedures that require cardiopulmonary bypass.

What evidence suggests that this trial's treatments could be effective for reducing acute kidney injury?

This trial will compare pulsatile blood flow with non-pulsatile blood flow during cardiopulmonary bypass. Research has shown that using pulsating blood flow during heart surgery can reduce the risk of sudden kidney problems, known as acute kidney injury (AKI). Studies have found that this type of blood flow improves kidney circulation, protecting them during the operation. This method decreases the likelihood of AKI and speeds up recovery. Additionally, patients using pulsating flow tend to spend less time in the intensive care unit (ICU) after surgery. Overall, evidence suggests that pulsating blood flow is more beneficial than steady flow in heart surgeries. ^{2 3 4 6 7}

Who Is on the Research Team?

Nathan Clendenen, MD MS

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for patients undergoing cardiac surgery who will be on cardiopulmonary bypass. It's not clear what specific conditions or characteristics make someone eligible or ineligible to participate.

Inclusion Criteria

Able to provide informed consent

I am scheduled for heart surgery that will use a heart-lung machine.

Exclusion Criteria

Emergency procedures

Scheduled for ventricular assist device implantation

I need medication to control my blood pressure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cardiopulmonary bypass with either pulsatile or non-pulsatile blood flow during cardiac surgery

Intra-operative period, up to 12 hours

Post-operative Monitoring

Participants are monitored for acute kidney injury and other clinical outcomes after surgery

Up to 30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Non-pulsatile blood flow
• Pulsatile blood flow

Trial Overview

The study is testing if pulsatile blood flow (mimicking natural heartbeat rhythms) during cardiopulmonary bypass can reduce kidney damage after heart surgery, compared to non-pulsatile flow (steady stream).

How Is the Trial Designed?

Group I: Pulsatile blood flow Active Control 1 Intervention

Pulsatile blood flow during cardiopulmonary bypass

Group II: Non-pulsatile blood flow Active Control 1 Intervention

Non-pulsatile blood flow during cardiopulmonary bypass

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06349577

Optimizing Pulsatility During Cardiopulmonary Bypass to ...

Hypothesis: Pulsatile blood flow during cardiopulmonary bypass will reduce the incidence of acute kidney injury after cardiac surgery compared to non-pulsatile ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S240584402500009X

Effects of pulsatile flow on postoperative recovery in adult ...

The use of pulsatile flow during CPB in heart surgery has a protective effect on patient recovery. It can reduce the incidence of AKI, shorten the ICU and ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7301695/

Incidence and impact of acute kidney injury on patients with ...

Our study shows that LVAD patients with severe AKI requiring RRT are associated with 7.5-fold and 5.4-fold increased risks of 30-day and 1-year mortality, ...

4.

withpower.com

withpower.com/trial/phase-hemolysis-3-2024-41deb

Pulsatile Blood Flow for Reducing Acute Kidney Injury

Studies found that pulsatile flow increases renal tissue perfusion and improves microcirculation, which can help protect the kidneys during surgery.

5.

nature.com

nature.com/articles/s41598-021-95924-5

In vitro investigation of the impact of pulsatile blood flow on ...

These reductions rose from roughly 40% after 12 h to 60% after 24 h. There were no apparent signs of clotting at the renal artery, renal vein, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7230860/

Diagnostics, Risk Factors, Treatment and Outcomes of ...

AKI is associated with significant morbidity, mortality, extra cost incurred in the hospitalization process, longer stay in the hospital, and long-term ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8983546/

Incidence of Acute Kidney Injury Is Lower in High-Risk ...

In this patient population, AKI is strongly associated with in-hospital mortality, increased risk for myocardial infarction (MI), and dialysis [ ...