Clinical trial NCT05344573: Optimizing Pulsatility During Cardiopulmonary Bypass
Official title: Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury: Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endothelial Dysfunction
Acute Kidney Injury
Keywords: Endothelial function
Acute Kidney Injury
Cardiopulmonary bypass
Cardiac surgery
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-04-25
Enrollment: 66
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients aged 50 to 70 years scheduled for elective cardiac surgery with cardiopulmonary bypass

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.

Eligibility criteria: Inclusion Criteria:

* Age 50 to 70
* Able to provide informed consent
* Scheduled for elective cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* 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

Primary outcomes:
measure: Endothelial function
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Secondary outcomes:
measure: Acute kidney injury
timeFrame: From intensive care unit admission after surgery to intensive care unit discharge, up to 7 days
measure: Renal blood flow velocity
timeFrame: Intra-operative time point: after cardiopulmonary bypass, up to 12 hours
measure: Acute kidney injury risk
timeFrame: Measured 4 hours after the end of cardiopulmonary bypass, up to 12 hours
measure: Perioperative death
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: Myocardial infarction
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: Stroke
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: New renal failure requiring renal replacement therapy
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: Re-exploration for bleeding
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: Post-operative sepsis
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: New onset atrial fibrillation
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: Post-operative blood loss
timeFrame: From intensive care unit admission to 24 hours after intensive care unit admission, up to 24 hours
measure: Duration of mechanical ventilation
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: Post-operative delirium
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: Post-operative hospital length of stay
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: New requirement for mechanical circulatory support
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: Intra-operative red blood cell transfusion
timeFrame: During the intra-operative time period, up to 12 hours
measure: Post-operative red blood cell transfusion
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: Post-operative platelet transfusion
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: Post-operative plasma transfusion
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: Post-operative cryoprecipitate transfusion
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: Intra-operative platelet transfusion
timeFrame: During the intra-operative time period, up to 12 hours
measure: Intra-operative plasma transfusion
timeFrame: During the intra-operative time period, up to 12 hours
measure: Intra-operative cryoprecipitate transfusion
timeFrame: During the intra-operative time period, up to 12 hours
measure: Glycocalyx thickness
timeFrame: Start of the intra-operative period to 24 hours after intensive care unit admission
measure: Microvascular circulatory function
timeFrame: Start of the intra-operative period to 24 hours after intensive care unit admission
measure: New onset of acute lung injury
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: New onset of left ventricular diastolic dysfunction
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: New onset of left ventricular systolic dysfunction
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
measure: New onset of right ventricular systolic dysfunction
timeFrame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado Denver | Anschutz
name: Nathan J Clendenen, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: