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.
After cardiac surgery under cardiopulmonary bypass (CPB) patients often show impairments of the immune system. Compared to placebo, CPB patients given alkaline phosphatase will have reduced composite endpoint of acute kidney injury (AKI), late extubation, gastrointestinal or neurological complications within 7 days and AKI within 90 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,250
Dept. Cardiothoracic Surgery , Monash Medical Centre
Number of patients with acute kidney injury
AKIN criteria: Rise in serum creatinine of by 0.3 mg/dl or 26 µmol/L in 48 hours/ a percentage increase in the serum creatinine concentration of more than 50 percent or a drop in urine output to 0.5 ml/kg/hour for 6 hours
Time frame: 90 days
reach haemodynamic stability
Demonstrate that RESCAP® intervention reduces the time at ICU to reach haemodynamic stability
Time frame: 7 days
cost-related outcome
Cost (SGD) incurred on renal replacement therapy, ICU and hospital stay
Time frame: 30 days
levels of a set of inflammatory markers
IL-6, IL-8, IL-10, IL-17, TNF-alpha
Time frame: 4 days
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Clayton, Melbourne, Australia
Division of Cardiac Surgery, Department of Surgery, LKH Medical University of Graz
Graz, Austria
NOT_YET_RECRUITINGMedUniWien / AKH-Wien
Vienna, Austria
RECRUITINGDepartment of Intensive Care, CHU Saint-Pierre, Université Libre de Bruxelles (ULB)
Brussels, Belgium
NOT_YET_RECRUITINGDepartment of Intensive Care, Hôpital Universitaire de Bruxelles (HUB)
Brussels, Belgium
NOT_YET_RECRUITINGHospital ZOL
Genk, Belgium
SUSPENDEDDept. of Anesthesia and Intensive Care, AZ Maria Middelares
Ghent, Belgium
RECRUITINGJessa Ziekenhuis,Campus Virga Jesse
Hasselt, Belgium
RECRUITINGGerman Heart Centre Munich, Dept.Cardio-Vascular Surgery
Munich, Bavaria, Germany
NOT_YET_RECRUITINGKlinik für Herzchirurgie, Universitätsklinik
Leipzig, Germany
SUSPENDED...and 11 more locations