Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase
Preventing Oxidative Stress-induced Ischemic Injury- and Systemic Inflammation Complications During and After Invasive Cardiac Surgery With Alkaline Phosphatase (APPIRED III)
Alloksys Life Sciences B.V.
1,250 participants
Nov 1, 2017
INTERVENTIONAL
Conditions
Summary
Study should demonstrate that alkaline phosphatase reduces the incidence and extent of acute kidney injury after cardiopulmonary bypass (CPB) as defined by the AKIN criteria.
Eligibility
Inclusion Criteria3
- Undergoing cardiac surgery with planned cardiopulmonary bypass
- Additive Euroscore II ≥ 3 OR at least 3 surgical cardiac interventions are planned
- Ability to provide informed consent (not incapacitated)
Exclusion Criteria7
- Already on renal replacement therapy
- Patients with chronic kidney disease defined as estimated glomerular filtration rate \[eGFR\] < 30 mL/min/1.73 m2 \[ CKD stage > 3 \]
- Patients who are pregnant or lactating
- Concurrent enrollment in another clinical trial
- Known allergic reaction to bovine alkaline phosphatase or patient is vegetarian or vegan
- Patients with ongoing infections or current use of steroids
- Patients with high-risk emergency surgery or with follow-up procedures already planned at admission (like e.g. TEVAR)
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Interventions
intravenous application before, during, and for 24 or 96 hours after heart surgery
intravenous application before, during, and for 24 or 96 hours after heart surgery
Locations(21)
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NCT03050476