Optimizing pulsatility during cardiopulmonary bypass to reduce acute kidney injury
Project Number5K23HL151882-05
Contact PI/Project LeaderCLENDENEN, NATHAN
Awardee OrganizationUNIVERSITY OF COLORADO DENVER
Description
Abstract Text
PROJECT SUMMARY/ABSTRACT
The long term goal of the proposal is to determine the role of pulsatility during cardiopulmonary bypass (CPB)
for preserving endothelial function and preventing organ injury after cardiac surgery. More than 400,000 people
undergo cardiac surgery in the United States each year which allows them to live longer and more fulfilling lives,
but if the surgery is complicated by acute kidney injury (AKI) mortality increases up to 10-fold. Dr. Clendenen is
a Cardiothoracic Anesthesiologist dedicated to improving clinical outcomes after cardiac procedures and this
K23 proposal is designed to provide him with the structured mentorship and training necessary to become a
leader in innovative clinical trials designed to improve patient outcomes. He has developed a collaborative
mentorship team led by Dr. Adit Ginde who is an Emergency Medicine Physician and national PI for a large
PETAL network clinical trial with 3,000 participants, with co-mentorship provided by Dr. Sarah Faubel, an expert
in renal disease research, and Dr. Kristen Jablonski Nowak, a recognized leader in endothelial function.
Methodological advisors include Dr. Alex Kaizer (Biostatistics) and Dr. Kerrie Moreau (Vascular Biology). This
proposal leverages the collective expertise of an established mentorship team and the unique environment at
the University of Colorado Anschutz Medical Center that incorporates a tertiary referral center for cardiac surgery
in the setting of a large public research University. These ample resources will allow Dr. Clendenen to address
key barriers to reducing morbidity and mortality after cardiac surgery with an adaptive clinical trial comparing the
incidence of AKI after cardiac surgery with pulsatile versus non-pulsatile CPB. He will accomplish this by
determining the effect of pulsatile CPB on post-operative endothelial function in a prospective observational
cohort (Aim 1), determining the timing of endothelial dysfunction and renal injury after cardiac surgery in the
same cohort (Aim 2), and determining the optimal level and efficacy of pulsatility during CPB to prevent AKI with
an adaptive seamless phase IIa/IIb clinical trial (Aim 3). These specific aims require Dr. Clendenen to develop
expertise in assessing clinical endothelial function and AKI risk and designing and completing an adaptive clinical
trial. He will accomplish this with a focused career development plan including coursework on clinical trial design
and biostatistics alongside structured training in assessing endothelial function to measure the effects of CPB.
Completion of the proposed project will provide the necessary mentorship, training, and experience required to
allow Dr. Clendenen to become a leader in adaptive clinical trials to improve outcomes after cardiac surgery.
Public Health Relevance Statement
PROJECT NARRATIVE
Cardiac surgery is effective for improving the health of patients with cardiovascular disease, but many patients
experience complications such as acute kidney injury (AKI) that result in an increased risk of death after surgery.
Maintaining normal pulsatile blood flow with the heart lung machine during cardiac surgery may prevent AKI after
cardiac surgery even though increased mechanical pulsatility damages red blood cells. This trial will identify to
best level of pulsatility during cardiac surgery for minimizing red blood cell damage while preventing AKI.
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