NCT06349577

Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,100 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Acute Kidney Injury
• Hemolysis
• Thrombocytopenia
• Surgery

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-05-19
• Primary completion: 2028-04-01
• Completion: 2028-10-01
• First posted: 2024-04-05
• Last updated: 2025-05-21

Locations

1 site across 1 country: United States