This multi-centre prospective, randomised, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of bovine intestinal alkaline phosphatase (bIAP) in reducing the pro-inflammatory post-surgical responses and thereby preserving organ functions in patients undergoing invasive cardiac surgery: combined aortic valve replacement and coronary artery bypass grafting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
53
intravenous as a bolus of bIAP (bovine intestinal alkaline phosphatase, 1000 IU) just prior to surgery followed by a 40 IU/kg bIAP infusion during the first 8 hours post surgery.
intravenous as a bolus just prior to surgery followed by an infusion during the first 8 hours post surgery.
Catharina Ziekenhuis, Dept. CardioThoracic Surgery
Eindhoven, Netherlands
TNF-alpha
as indicator of post-surgical inflammatory response
Time frame: one day before till 5 days post surgery
incidence of new organ dysfunctions
Time frame: till 30 days post surgery
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