Systemic Inflammation Clinical Trial
— APPIRED-IIIOfficial title:
Preventing Oxidative Stress-induced Ischemic Injury- and Systemic Inflammation Complications During and After Invasive Cardiac Surgery With Alkaline Phosphatase (APPIRED III)
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.
Status | Recruiting |
Enrollment | 1250 |
Est. completion date | March 31, 2026 |
Est. primary completion date | September 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
Australia | Dept. Cardiothoracic Surgery , Monash Medical Centre | Clayton | Melbourne |
Austria | Division of Cardiac Surgery, Department of Surgery, LKH Medical University of Graz | Graz | |
Austria | MedUniWien / AKH-Wien | Wien | |
Belgium | Department of Intensive Care, CHU Saint-Pierre, Université Libre de Bruxelles (ULB) | Brussels | |
Belgium | Department of Intensive Care, Hôpital Universitaire de Bruxelles (HUB) | Brussels | |
Belgium | Hospital ZOL | Genk | |
Belgium | Dept. of Anesthesia and Intensive Care, AZ Maria Middelares | Gent | |
Belgium | Jessa Ziekenhuis,Campus Virga Jesse | Hasselt | |
Germany | Klinik für Herzchirurgie, Universitätsklinik | Leipzig | |
Germany | German Heart Centre Munich, Dept.Cardio-Vascular Surgery | Munich | Bavaria |
Italy | Policlinico Gemelli, Institute Cardiology | Roma | |
Italy | U.O.C. Cardiochirurgia e Trapianti di Cuore, Azienda Ospedaliera San Camillo Forlanini | Roma | |
Malaysia | Institut Jantung Negara (IJN , Natl. Heart Inst.) | Kuala Lumpur | |
Netherlands | Catharina Ziekenhuis, Cathreine R&D, Heartcentre | Eindhoven | |
Netherlands | Dept. Cardiothoracic Surgery, Maastricht University Medical Centre | Maastricht | Limburg |
Portugal | Hospital de Santa Marta | Lisboa | |
Russian Federation | State Autonomous Healthcare Institution "Interregional Clinical Diagnostic Center" | Kazan | |
Russian Federation | Federal State Budgetary Military Educational Institution of the Higher Education | Saint Petersburg | |
Russian Federation | Almazov Heart Center | St Petersburg | |
Singapore | National University Hospital (NUH), | Singapore | |
Spain | Jefe de Servicio de Cirugía Cardiovascular, Hospital Universitario La Princesa | Madrid |
Lead Sponsor | Collaborator |
---|---|
Alloksys Life Sciences B.V. | Aix Scientifics |
Australia, Austria, Belgium, Germany, Italy, Malaysia, Netherlands, Portugal, Russian Federation, Singapore, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 90 days | |
Primary | reach haemodynamic stability | Demonstrate that RESCAP® intervention reduces the time at ICU to reach haemodynamic stability | 7 days | |
Secondary | cost-related outcome | Cost (SGD) incurred on renal replacement therapy, ICU and hospital stay | 30 days | |
Secondary | levels of a set of inflammatory markers | IL-6, IL-8, IL-10, IL-17, TNF-alpha | 4 days |
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