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NCT06349577 | RECRUITING | Acute Kidney Injury

Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury
Sponsor:

University of Colorado, Denver

Brief 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.

Condition or disease

Acute Kidney Injury

Hemolysis

Thrombocytopenia

Surgery

Intervention/treatment

Non-pulsatile blood flow

Pulsatile blood flow

Phase

NA

Detailed Description:

Non-pulsatile and pulsatile blood flow during cardiopulmonary bypass for cardiac surgery are both considered standard of care and allow surgeons to operate on the heart without movement. Pulsatile cardiopulmonary bypass produces variations in blood flow to produce a pulse similar to a normal beating heart. Non-pulsatile and pulsatile blood flow during cardiopulmonary bypass are approved as safe and effective ways to provide perfusion during cardiac surgery, but it is unknown whether there are differences in clinical outcomes after surgery. Acute kidney injury is common after cardiac surgery and may be caused by inadequate perfusion during cardiopulmonary bypass. Specific Aim: The purpose of this study is to determine the effectiveness of pulsatile blood flow during cardiopulmonary bypass to reduce the incidence of acute kidney injury after cardiac surgery compared to non-pulsatile blood flow. Hypothesis: Pulsatile blood flow during cardiopulmonary bypass will reduce the incidence of acute kidney injury after cardiac surgery compared to non-pulsatile blood flow.

Study Type : INTERVENTIONAL
Estimated Enrollment : 1100 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury: Randomized Controlled Trial
Actual Study Start Date : 2025-05-19
Estimated Primary Completion Date : 2028-04
Estimated Study Completion Date : 2028-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Able to provide informed consent
  • * Scheduled for elective cardiac surgery with cardiopulmonary bypass
Exclusion Criteria
  • * 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
    • Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury

    Location Details

    NCT06349577

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    How to Participate

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    Locations

    RECRUITING

    United States, Colorado

    University of Colorado Hospital

    Aurora, Colorado, United States, 80045