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

Trial Summary

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.

What data supports the effectiveness of the treatment Pulsatile Blood Flow for reducing acute kidney injury?

Research shows that pulsatile blood flow improves kidney function and tissue perfusion (blood flow to tissues) during procedures like cardiopulmonary bypass. Studies found that pulsatile flow increases renal tissue perfusion and improves microcirculation, which can help protect the kidneys during surgery. ^{1 2 3 4 5}

Is pulsatile blood flow generally safe for humans?

Research indicates that pulsatile blood flow can improve kidney function and microcirculation during certain medical procedures, suggesting it is generally safe. However, more studies are needed to fully understand its long-term effects on other vital organs. ^{1 2 3 5 6}

How does pulsatile blood flow treatment differ from other treatments for reducing acute kidney injury?

Pulsatile blood flow treatment is unique because it mimics the natural heartbeat, improving blood flow and oxygen delivery to the kidneys, which can enhance kidney function and prevent damage. This approach contrasts with nonpulsatile flow, which can increase resistance and pressure, potentially leading to organ damage if used for extended periods. ^{1 2 7 8 9}

What is the purpose of this trial?

The objective is to determine the effectiveness of pulsatile flow during cardiopulmonary bypass to reduce the incidence of acute kidney injury after cardiac surgery. Investigators will also evaluate the safety and impact of pulsatile flow on clinical outcomes compared to non-pulsatile flow during cardiopulmonary bypass.

Research Team

Nathan Clendenen, MD MS

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

To pulse or not to pulse. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The effects of pulsatile flow upon renal tissue perfusion during cardiopulmonary bypass: a comparative study of pulsatile and nonpulsatile flow. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Pediatric physiologic pulsatile pump enhances cerebral and renal blood flow during and after cardiopulmonary bypass. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The Association Between Pulsatile Cardiopulmonary Bypass and Acute Kidney Injury After Cardiac Surgery: A Before-and-After Study. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Pulsatile flow improves renal function in high-risk cardiac operations. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of nonpulsatile and pulsatile extracorporeal circulation on renal cortical blood flow. [2019]

7. Japan pubmed.ncbi.nlm.nih.gov

[Microcirculation of kidney and skin during left ventricular assisted circulation--comparative studies of pulsatile and nonpulsatile assists]. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Effect of Pulsatile and Nonpulsatile Assist on Heart and Kidney Microcirculation with Cardiogenic Shock. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Effect of pulsatile and nonpulsatile assist on heart and kidney microcirculation with cardiogenic shock. [2003]