Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury

Not Applicable

Not yet recruiting

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.

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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Non-pulsatile blood flow	Non-pulsatile blood flow	Non-pulsatile blood flow during cardiopulmonary bypass
Pulsatile blood flow	Pulsatile blood flow	Pulsatile blood flow during cardiopulmonary bypass

Primary Outcome Measures

Name	Time	Method
Acute kidney injury	From intensive care unit admission after surgery up to 7 days	Stage 1 (mild), 2 (moderate), or 3 (severe) acute kidney injury according to the Kidney Disease Improving Global Outcomes creatinine criteria (stage 1 = 1.5 to 1.9 times baseline or greater than or equal to 0.3 milligrams per deciliter increase in serum creatinine, stage 2 = 2.0 to 2.9 times baseline in serum creatinine, stage 3 = 3.0 times baseline or increase in serum creatinine greater than or equal to 4.0 milligrams per deciliter or initiation of renal replacement therapy

Secondary Outcome Measures

Name	Time	Method
Acute kidney injury risk score	On admission to the intensive care unit after surgery up to 24 hours after intensive care unit arrival	Demirjian Perioperative Laboratory Test-Based Prediction Model for Moderate to Severe Acute Kidney Injury After Cardiac Surgery in percent predicted risk
Red blood cell units transfused	After cardiopulmonary bypass up to 24 hours after intensive care unit arrival	Number of allogenic red blood cell units transfused after cardiopulmonary bypass
Platelet nadir	On admission to the intensive care unit after surgery up to 7 days	Lowest platelet count after cardiopulmonary bypass
30-day mortality	From intensive care unit admission after surgery to hospital discharge, up to 30 days	All cause mortality
Discontinuation rate of cardiopulmonary bypass mode	During cardiopulmonary bypass	Discontinuation rate of pulsatile or non-pulsatile cardiopulmonary bypass mode

Locations (1): University of Colorado Hospital
🇺🇸
Aurora, Colorado, United States

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