Acute Kidney Injury, Hemolysis, Surgery, Thrombocytopenia
Conditions
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.
Interventions
OTHERPulsatile blood flow
Pulsatile blood flow generated by variable centrifugal pump flow rate during cardiopulmonary bypass
OTHERNon-pulsatile blood flow
Non-pulsatile blood flow generated by constant centrifugal pump flow rate during cardiopulmonary bypass
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Discontinuation rate of cardiopulmonary bypass mode | During cardiopulmonary bypass | Discontinuation rate of pulsatile or non-pulsatile cardiopulmonary bypass mode |
| 30-day mortality | From intensive care unit admission after surgery to hospital discharge, up to 30 days | All cause mortality |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of mechanical ventilation | From intensive care unit admission after surgery to hospital discharge, up to 30 days | Duration of mechanical ventilation |
| Post-operative delirium | From intensive care unit admission after surgery to hospital discharge, up to 30 days | Post-operative determined by the Confusion Assessment Method for the Intensive Care Unit |
| Post-operative hospital length of stay | From intensive care unit admission after surgery to hospital discharge, up to 30 days | Post-operative hospital length of stay |
| New requirement for mechanical circulatory support | From intensive care unit admission after surgery to hospital discharge, up to 30 days | New requirement for mechanical circulatory support |
| Intra-operative red blood cell transfusion in units | During the intra-operative time period, up to 12 hours | Intra-operative red blood cell transfusion in units |
| Post-operative red blood cell transfusion in units | From intensive care unit admission after surgery to hospital discharge, up to 30 days | Post-operative red blood cell transfusion in units |
| Post-operative platelet transfusion in units | From intensive care unit admission after surgery to hospital discharge, up to 30 days | Post-operative platelet transfusion in units |
| Myocardial infarction | From intensive care unit admission after surgery to hospital discharge, up to 30 days | Myocardial infarction by clinical diagnosis |
| Post-operative cryoprecipitate transfusion in units | From intensive care unit admission after surgery to hospital discharge, up to 30 days | Post-operative cryoprecipitate transfusion in units |
| Intra-operative platelet transfusion in units | During the intra-operative time period, up to 12 hours | Intra-operative platelet transfusion in units |
| Intra-operative plasma transfusion in units | During the intra-operative time period, up to 12 hours | Intra-operative plasma transfusion in units |
| Intra-operative cryoprecipitate transfusion in units | During the intra-operative time period, up to 12 hours | Intra-operative cryoprecipitate transfusion in units |
| New onset of acute lung injury | From intensive care unit admission after surgery to hospital discharge, up to 30 days | Diagnosis of acute lung injury by PaO2 to FiO2 ratio ≤ 300 |
| New onset of left ventricular systolic dysfunction | From intensive care unit admission after surgery to hospital discharge, up to 30 days | New onset of left ventricular systolic dysfunction determined by a LV ejection fraction \<50% |
| New onset of right ventricular systolic dysfunction | From intensive care unit admission after surgery to hospital discharge, up to 30 days | New onset of right ventricular systolic dysfunction determined by a tricuspid annular plane systolic excursion less than 16 mm |
| Post-operative plasma transfusion in units | From intensive care unit admission after surgery to hospital discharge, up to 30 days | Post-operative plasma transfusion in units |
| Stroke | From intensive care unit admission after surgery to hospital discharge, up to 30 days | Stroke by clinical diagnosis |
| Renal failure requiring renal replacement therapy | From intensive care unit admission after surgery to hospital discharge, up to 30 days | New diagnosis of renal failure requiring renal replacement therapy |
| Re-exploration for bleeding | From intensive care unit admission after surgery to hospital discharge, up to 30 days | Surgical re-exploration for bleeding |
| Sepsis | From intensive care unit admission after surgery to hospital discharge, up to 30 days | Diagnosed by positive blood culture |
| New onset atrial fibrillation | From intensive care unit admission after surgery to hospital discharge, up to 30 days | Clinical diagnosis of new onset atrial fibrillation |
Countries
United States
Contacts
Primary ContactNathan J Clendenen, MD,MS
Outcome results
None listed