Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Colorado, Denver
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to provide informed consent
Scheduled for elective cardiac surgery with cardiopulmonary bypass
Disqualifiers
Emergency procedures
Scheduled for heart or lung transplantation
Scheduled for ventricular assist device implantation
Use of the Medtronic Elongated Once-Piece Arterial Cannula
Trial design
Design model
Parallel
Treatments tested in this trial
Non-pulsatile blood flow
Other interventionNon-pulsatile blood flow generated by constant centrifugal pump flow rate during cardiopulmonary bypass
Pulsatile blood flow
Other interventionPulsatile blood flow generated by variable centrifugal pump flow rate during cardiopulmonary bypass
Treatment groups
1,100 Participants
are divided into 2 treatment groupsGroup A: Non-pulsatile blood flowActive comparator 1 intervention
Group B: Pulsatile blood flowActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Acute 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 daysSecondary outcomes
1
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 arrival2
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 arrival3
Platelet nadir
Lowest platelet count after cardiopulmonary bypass
Time frame
On admission to the intensive care unit after surgery up to 7 days4
Discontinuation rate of cardiopulmonary bypass mode
Discontinuation rate of pulsatile or non-pulsatile cardiopulmonary bypass mode
Time frame
During cardiopulmonary bypassOther outcomes
1
Myocardial infarction
Myocardial infarction by clinical diagnosis
Time frame
From intensive care unit admission after surgery to hospital discharge, up to 30 days2
Stroke
Stroke by clinical diagnosis
Time frame
From intensive care unit admission after surgery to hospital discharge, up to 30 days3
Renal failure requiring renal replacement therapy
New diagnosis of renal failure requiring renal replacement therapy
Time frame
From intensive care unit admission after surgery to hospital discharge, up to 30 days4
Re-exploration for bleeding
Surgical re-exploration for bleeding
Time frame
From intensive care unit admission after surgery to hospital discharge, up to 30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov