Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase
- Conditions
- Systemic InflammationCardiopulmonary-bypass
- Interventions
- Drug: RESCAP®Drug: placebo
- Registration Number
- NCT03050476
- Lead Sponsor
- Alloksys Life Sciences B.V.
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1250
- 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)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RESCAP® RESCAP® Bolus of 1000 IU of bovine intestinal alkaline phosphatase on induction of anaesthesia, followed by an infusion with a sum of 10,000 IU/day over the next 24 or 96 hours. Placebo placebo Bolus of of media on induction of anaesthesia, followed by an infusion of media over the next 24 or 96 hours.
- Primary Outcome Measures
Name Time Method Number of patients with acute kidney injury 90 days 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
reach haemodynamic stability 7 days Demonstrate that RESCAP® intervention reduces the time at ICU to reach haemodynamic stability
- Secondary Outcome Measures
Name Time Method cost-related outcome 30 days Cost (SGD) incurred on renal replacement therapy, ICU and hospital stay
levels of a set of inflammatory markers 4 days IL-6, IL-8, IL-10, IL-17, TNF-alpha
Trial Locations
- Locations (21)
Dept. of Anesthesia and Intensive Care, AZ Maria Middelares
🇧🇪Gent, Belgium
Almazov Heart Center
🇷🇺St Petersburg, Russian Federation
Klinik für Herzchirurgie, Universitätsklinik
🇩🇪Leipzig, Germany
Hospital de Santa Marta
🇵🇹Lisboa, Portugal
Federal State Budgetary Military Educational Institution of the Higher Education
🇷🇺Saint Petersburg, Russian Federation
Policlinico Gemelli, Institute Cardiology
🇮🇹Roma, Italy
Dept. Cardiothoracic Surgery, Maastricht University Medical Centre
🇳🇱Maastricht, Limburg, Netherlands
Jefe de Servicio de Cirugía Cardiovascular, Hospital Universitario La Princesa
🇪🇸Madrid, Spain
National University Hospital (NUH),
🇸🇬Singapore, Singapore
Division of Cardiac Surgery, Department of Surgery, LKH Medical University of Graz
🇦🇹Graz, Austria
Department of Intensive Care, CHU Saint-Pierre, Université Libre de Bruxelles (ULB)
🇧🇪Brussels, Belgium
Institut Jantung Negara (IJN , Natl. Heart Inst.)
🇲🇾Kuala Lumpur, Malaysia
Department of Intensive Care, Hôpital Universitaire de Bruxelles (HUB)
🇧🇪Brussels, Belgium
German Heart Centre Munich, Dept.Cardio-Vascular Surgery
🇩🇪Munich, Bavaria, Germany
Dept. Cardiothoracic Surgery , Monash Medical Centre
🇦🇺Clayton, Melbourne, Australia
MedUniWien / AKH-Wien
🇦🇹Wien, Austria
Hospital ZOL
🇧🇪Genk, Belgium
Jessa Ziekenhuis,Campus Virga Jesse
🇧🇪Hasselt, Belgium
U.O.C. Cardiochirurgia e Trapianti di Cuore, Azienda Ospedaliera San Camillo Forlanini
🇮🇹Roma, Italy
Catharina Ziekenhuis, Cathreine R&D, Heartcentre
🇳🇱Eindhoven, Netherlands
State Autonomous Healthcare Institution "Interregional Clinical Diagnostic Center"
🇷🇺Kazan, Russian Federation