University of Colorado Hospital
Aurora, Colorado, 80045, United States
Location status: Recruiting
Location contact
Nathan Clendenen, MD MS
CONTACT
Nathan J Clendenen, MD MS
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05344573
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.
Interested in participating?
Request Info50 year–70 year
All sexes
Observational
Aurora, Colorado, 80045, United States
Location status: Recruiting
Nathan Clendenen, MD MS
CONTACT
Nathan J Clendenen, MD MS
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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
Time frame: From intensive care unit admission after surgery to intensive care unit discharge, up to 7 days
Acute kidney injury by the KDIGO criteria
Time frame: Intra-operative time point: after cardiopulmonary bypass, up to 12 hours
Renal blood flow velocity measured by pulse wave doppler
Time frame: Measured 4 hours after the end of cardiopulmonary bypass, up to 12 hours
Acute kidney injury risk measured by urinary TIMP2*IGFBP7
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Death after surgery during the surgical hospital encounter
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Myocardial infarction after surgery
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Stroke after surgery
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
New renal failure requiring renal replacement therapy after surgery
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Need for surgical re-exploration to control hemorrhage
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Post-operative sepsis determined by positive blood culture
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Post-operative new onset atrial fibrillation
Time frame: 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
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Duration of mechanical ventilation after surgery
Time frame: 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
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Duration of hospital stay after surgery
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Post-operative initiation of mechanical circulatory support
Time frame: During the intra-operative time period, up to 12 hours
Intra-operative red blood cell transfusion in units
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Post-operative red blood cell transfusion in units
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Post-operative platelet transfusion in units
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Post-operative plasma transfusion in units
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Post-operative cryoprecipitate transfusion in units
Time frame: During the intra-operative time period, up to 12 hours
Intra-operative platelet transfusion in units
Time frame: During the intra-operative time period, up to 12 hours
Intra-operative plasma transfusion in units
Time frame: During the intra-operative time period, up to 12 hours
Intra-operative cryoprecipitate transfusion in units
Time frame: Start of the intra-operative period to 24 hours after intensive care unit admission
Glycocalyx thickness determined by sublingual microcirculation microscopy
Time frame: Start of the intra-operative period to 24 hours after intensive care unit admission
Microvascular circulatory function determined by sublingual microcirculation microscopy
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Diagnosis of acute lung injury by PaO2 to FiO2 ratio
Time frame: 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.
Time frame: 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%
Time frame: 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
Contact information is provided by the study sponsor or research team.
University of Colorado, Denver
Other
Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury: Prospective Observational Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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