The purpose of the present research study is to investigate the pharmacokinetics, as well as safety, tolerability and pharmacodynamics of different ascending dosing regimens of AP214 in patients undergoing cardiac surgery. AP214, the investigational drug, is being developed to potentially prevent post-surgical kidney injury after thoracic aortic aneurysm repair.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
42
Department of Cardiac and Thoracic Surgery, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark
Odense University Hospital, Department of Cardiac, Thoracic and Vascular Surgery
Odense, Denmark
To assess in patients the pharmacokinetics of AP214 administered as three 10-minute infusions in patients undergoing cardiac surgery.
Time frame: Day 0 to Day 1
To assess the safety and tolerability of AP214, defined as a descriptive analysis of AEs and SAEs (including analysis of severity and relationship to trial drug)
Time frame: Day 0-90
To assess effect of AP214 on cardiac surgery induced systemic inflammation o determined by the post-operative peak plasma concentrations of TNF-α, IL-6, IL-8, and IL-10, and area under the curve (AUC) for TNF-α, IL-6, IL-8, and IL-10
Time frame: 0-24 hours
To assess effect of AP214 on development of post-surgical acute kidney injury (AKI), where AKI is evaluated by evaluation of serum creatinine values, urine output and renal replacement therapy free days.
Time frame: Day 0 - Day 30
To assess the safety and tolerability of AP214 on standard safety laboratory data
Time frame: Day 0-14
To assess the safety and tolerability of AP214 on vital signs
Time frame: Day 0-90
To assess safety and tolerability of AP214 in terms of mortality by evaluation of overall mortality
Time frame: Day 0-90
To assess the effect of AP214 at an organ level (CNS, heart, lung, and wound healing)as well as systemically.
Time frame: Day 0-90
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