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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,100
Non-pulsatile blood flow generated by constant centrifugal pump flow rate during cardiopulmonary bypass
Pulsatile blood flow generated by variable centrifugal pump flow rate during cardiopulmonary bypass
University of Colorado Hospital
Aurora, Colorado, United States
RECRUITINGAcute kidney injury
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
Time frame: From intensive care unit admission after surgery up to 7 days
Acute kidney injury risk score
Demirjian Perioperative Laboratory Test-Based Prediction Model for Moderate to Severe Acute Kidney Injury After Cardiac Surgery in percent predicted risk
Time frame: On admission to the intensive care unit after surgery up to 24 hours after intensive care unit arrival
Red blood cell units transfused
Number of allogenic red blood cell units transfused after cardiopulmonary bypass
Time frame: After cardiopulmonary bypass up to 24 hours after intensive care unit arrival
Platelet nadir
Lowest platelet count after cardiopulmonary bypass
Time frame: On admission to the intensive care unit after surgery up to 7 days
Discontinuation rate of cardiopulmonary bypass mode
Discontinuation rate of pulsatile or non-pulsatile cardiopulmonary bypass mode
Time frame: During cardiopulmonary bypass
30-day mortality
All cause mortality
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
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