Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury
NCT06349577 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1100
Last updated 2025-05-21
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.
Conditions
- Acute Kidney Injury
- Hemolysis
- Thrombocytopenia
- Surgery
Interventions
- OTHER
-
Non-pulsatile blood flow
Non-pulsatile blood flow generated by constant centrifugal pump flow rate during cardiopulmonary bypass
- OTHER
-
Pulsatile blood flow
Pulsatile blood flow generated by variable centrifugal pump flow rate during cardiopulmonary bypass
Sponsors & Collaborators
-
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH -
University of Colorado, Denver
lead OTHER
Principal Investigators
-
Nathan J Clendenen, MD, MS · University of Colorado, Denver
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-19
- Primary Completion
- 2028-04-30
- Completion
- 2028-10-31
Countries
- United States
Study Locations
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