Optimizing Pulsatility During Cardiopulmonary Bypass
- Conditions
- Endothelial DysfunctionAcute Kidney Injury
- Registration Number
- NCT05344573
- Lead Sponsor
- University of Colorado, Denver
- Brief Summary
Cardiopulmonary bypass during cardiac surgery provides blood flow to the body during surgery but has adverse effects on different organs. Blood flow during cardiopulmonary bypass may be pulsatile or non-pulsatile, which may impact normal organ function after surgery. The study will collect data on the type of cardiopulmonary bypass used during surgery and organ function to determine if there is an association between the type of bypass and organ function.
- Detailed Description
Cardiac surgery is a high-risk elective surgical procedure frequently requiring CPB in which a machine pumps blood while the surgeon operates on the heart. CPB contributes to surgical risk by causing endothelial dysfunction and acute kidney injury (AKI). Endothelial dysfunction and AKI happen because heart lung machines typically generate non-pulsatile blood flow, which is abnormal and results in impaired tissue oxygen delivery. Normal blood flow is pulsatile due intermittent contraction and relaxation of the heart during the cardiac cycle, which produces a mechanical signal that induces endothelial cells to produce nitric oxide. Without nitric oxide, blood flow does not penetrate as deeply into organs such as the kidneys which leads to acute kidney injury. AKI increases mortality 10-fold after cardiac surgery placing many people at risk since over 400,000 people have surgery with CPB each year in the United States. Thus, pulsatile CPB may influence endothelial function and renal blood flow after cardiac surgery. This study will observe patients undergoing cardiac surgery with CPB and compare patients who receive pulsatile or non-pulsatile CPB.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 66
- Age 50 to 70
- Able to provide informed consent
- Scheduled for elective cardiac surgery with cardiopulmonary bypass
- Patients undergoing emergency procedures
- Diagnosed with sepsis
- Experiencing delirium
- Experiencing hemodynamic instability (heart rate > 100 and systolic blood pressure < 90)
- Patients with a mechanical circulatory support device
- Requiring vasoactive medications before surgery
- Patients with a reduced left ventricular ejection fraction (less than 50%)
- Patients with a contraindication to transesophageal echocardiography
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Endothelial function From intensive care unit admission after surgery to hospital discharge, up to 30 days Percent change in flow mediated dilation of the brachial artery after cardiac surgery
- Secondary Outcome Measures
Name Time Method Re-exploration for bleeding From intensive care unit admission after surgery to hospital discharge, up to 30 days Need for surgical re-exploration to control hemorrhage
Post-operative blood loss From intensive care unit admission to 24 hours after intensive care unit admission, up to 24 hours Post-operative blood loss determined by total surgical drain output
Acute kidney injury From intensive care unit admission after surgery to intensive care unit discharge, up to 7 days Acute kidney injury by the KDIGO criteria
Perioperative death From intensive care unit admission after surgery to hospital discharge, up to 30 days Death after surgery during the surgical hospital encounter
Myocardial infarction From intensive care unit admission after surgery to hospital discharge, up to 30 days Myocardial infarction after surgery
Renal blood flow velocity Intra-operative time point: after cardiopulmonary bypass, up to 12 hours Renal blood flow velocity measured by pulse wave doppler
New renal failure requiring renal replacement therapy From intensive care unit admission after surgery to hospital discharge, up to 30 days New renal failure requiring renal replacement therapy after surgery
Post-operative sepsis From intensive care unit admission after surgery to hospital discharge, up to 30 days Post-operative sepsis determined by positive blood culture
New onset atrial fibrillation From intensive care unit admission after surgery to hospital discharge, up to 30 days Post-operative new onset atrial fibrillation
Acute kidney injury risk Measured 4 hours after the end of cardiopulmonary bypass, up to 12 hours Acute kidney injury risk measured by urinary TIMP2\*IGFBP7
Stroke From intensive care unit admission after surgery to hospital discharge, up to 30 days Stroke after surgery
Duration of mechanical ventilation From intensive care unit admission after surgery to hospital discharge, up to 30 days Duration of mechanical ventilation after surgery
New requirement for mechanical circulatory support From intensive care unit admission after surgery to hospital discharge, up to 30 days Post-operative initiation of mechanical circulatory support
Post-operative delirium From intensive care unit admission after surgery to hospital discharge, up to 30 days Post-operative delirium determined by the Confusion Assessment Method for the Intensive Care Unit score
Post-operative hospital length of stay From intensive care unit admission after surgery to hospital discharge, up to 30 days Duration of hospital stay after surgery
Intra-operative red blood cell transfusion During the intra-operative time period, up to 12 hours Intra-operative red blood cell transfusion in units
Post-operative red blood cell transfusion 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 From intensive care unit admission after surgery to hospital discharge, up to 30 days Post-operative platelet transfusion in units
Post-operative plasma transfusion From intensive care unit admission after surgery to hospital discharge, up to 30 days Post-operative plasma transfusion in units
New onset of left ventricular diastolic dysfunction From intensive care unit admission after surgery to hospital discharge, up to 30 days Diagnosis new onset diastolic dysfunction by annular e' velocity: septal e' \< 7 cm/sec, lateral e' \<10 cm/sec, average E/e' ratio \> 14, LA volume index \> 34 mL/m2, and peak TR velocity \> 2.8 m/sec.
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 cryoprecipitate transfusion From intensive care unit admission after surgery to hospital discharge, up to 30 days Post-operative cryoprecipitate transfusion in units
Intra-operative platelet transfusion During the intra-operative time period, up to 12 hours Intra-operative platelet 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
Intra-operative plasma transfusion During the intra-operative time period, up to 12 hours Intra-operative plasma transfusion in units
Intra-operative cryoprecipitate transfusion During the intra-operative time period, up to 12 hours Intra-operative cryoprecipitate transfusion in units
Glycocalyx thickness Start of the intra-operative period to 24 hours after intensive care unit admission Glycocalyx thickness determined by sublingual microcirculation microscopy
Microvascular circulatory function Start of the intra-operative period to 24 hours after intensive care unit admission Microvascular circulatory function determined by sublingual microcirculation microscopy
Trial Locations
- Locations (1)
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States