Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury

University of Colorado Denver (CU Denver)

Status: Begins enrollment this month

Conditions: Hemolysis; Thrombocytopenia; Surgery; Acute Kidney Injury

Treatments: Other: Non-pulsatile blood flow; Other: Pulsatile blood flow

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06349577

5K23HL151882 (U.S. NIH Grant/Contract)

23-0921

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,100 participants in 2 patient groups

Non-pulsatile blood flow

Active Comparator group

Description:

Non-pulsatile blood flow during cardiopulmonary bypass

Treatment:

Other: Non-pulsatile blood flow

Pulsatile blood flow

Active Comparator group

Description:

Pulsatile blood flow during cardiopulmonary bypass

Treatment:

Other: Pulsatile blood flow