RecruitingNot ApplicableNCT06349577

Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury

Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury: Randomized Controlled Trial


Sponsor

University of Colorado, Denver

Enrollment

1,100 participants

Start Date

May 19, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria2

  • Able to provide informed consent
  • Scheduled for elective cardiac surgery with cardiopulmonary bypass

Exclusion Criteria9

  • Emergency procedures
  • Scheduled for heart or lung transplantation
  • Scheduled for ventricular assist device implantation
  • Use of the Medtronic Elongated Once-Piece Arterial Cannula
  • Diagnosed with sepsis
  • Diagnosed with delirium
  • Experiencing hemodynamic instability (heart rate > 100 and systolic blood pressure < 90)
  • Requiring mechanical circulatory support
  • Requiring vasoactive medications

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Interventions

OTHERNon-pulsatile blood flow

Non-pulsatile blood flow generated by constant centrifugal pump flow rate during cardiopulmonary bypass

OTHERPulsatile blood flow

Pulsatile blood flow generated by variable centrifugal pump flow rate during cardiopulmonary bypass


Locations(1)

University of Colorado Hospital

Aurora, Colorado, United States

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