Status:
RECRUITING
Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Acute Kidney Injury
Hemolysis
Eligibility:
All Genders
18-85 years
Phase:
NA
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 t...
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 car...
Eligibility 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
Key Trial Info
Start Date :
May 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT06349577
Start Date
May 19 2025
End Date
October 1 2028
Last Update
May 21 2025
Active Locations (1)
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1
University of Colorado Hospital
Aurora, Colorado, United States, 80045