Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Aix Scientifics | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RESCAP® | Experimental | 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 Comparator | Bolus of of media on induction of anaesthesia, followed by an infusion of media over the next 24 or 96 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RESCAP® | Drug | intravenous application before, during, and for 24 or 96 hours after heart surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| reach haemodynamic stability | Demonstrate that RESCAP® intervention reduces the time at ICU to reach haemodynamic stability | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| cost-related outcome | Cost (SGD) incurred on renal replacement therapy, ICU and hospital stay | 30 days |
| levels of a set of inflammatory markers | IL-6, IL-8, IL-10, IL-17, TNF-alpha |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruud Brands, PhD | Contact | +31 647 228 395 | ruud@alloksys.com | |
| Eike G Fischer, PhD | Contact | +49 241 4500 358 | eike@aix-scientifics.com |
| Name | Affiliation | Role |
|---|---|---|
| Ruud Brands, PhD | Alloksys Life Sciences BV . President | Study Chair |
| Dominik Wiedemann, Prof.Dr. | Universitätsklinikum St. Pölten, Austria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. Cardiothoracic Surgery , Monash Medical Centre | Terminated | Clayton | Melbourne | VIC 3168 | Australia | |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Drug | intravenous application before, during, and for 24 or 96 hours after heart surgery |
|
| 4 days |
| Division of Cardiac Surgery, Department of Surgery, LKH Medical University of Graz |
| Not yet recruiting |
| Graz |
| 8036 |
| Austria |
|
| MedUniWien / AKH-Wien | Recruiting | Vienna | 1090 | Austria |
|
| Department of Intensive Care, CHU Saint-Pierre, Université Libre de Bruxelles (ULB) | Not yet recruiting | Brussels | 1000 | Belgium |
|
| Department of Intensive Care, Hôpital Universitaire de Bruxelles (HUB) | Not yet recruiting | Brussels | 1070 | Belgium |
|
| Hospital ZOL | Suspended | Genk | 3600 | Belgium |
| Dept. of Anesthesia and Intensive Care, AZ Maria Middelares | Recruiting | Ghent | 9000 | Belgium |
|
| Jessa Ziekenhuis,Campus Virga Jesse | Recruiting | Hasselt | 3500 | Belgium |
|
| German Heart Centre Munich, Dept.Cardio-Vascular Surgery | Not yet recruiting | Munich | Bavaria | 80636 | Germany |
|
| Klinik für Herzchirurgie, Universitätsklinik | Suspended | Leipzig | 04289 | Germany |
| U.O.C. Cardiochirurgia e Trapianti di Cuore, Azienda Ospedaliera San Camillo Forlanini | Not yet recruiting | Roma | 00152 | Italy |
|
| Policlinico Gemelli, Institute Cardiology | Not yet recruiting | Roma | 00168 | Italy |
|
| Institut Jantung Negara (IJN , Natl. Heart Inst.) | Terminated | Kuala Lumpur | 50400 | Malaysia |
| Dept. Cardiothoracic Surgery, Maastricht University Medical Centre | Suspended | Maastricht | Limburg | 6229 HX | Netherlands |
| Catharina Ziekenhuis, Cathreine R&D, Heartcentre | Terminated | Eindhoven | 5623 EJ | Netherlands |
| Hospital de Santa Marta | Not yet recruiting | Lisbon | 1169-024 | Portugal |
|
| State Autonomous Healthcare Institution "Interregional Clinical Diagnostic Center" | Terminated | Kazan' | 420101 | Russia |
| Federal State Budgetary Military Educational Institution of the Higher Education | Terminated | Saint Petersburg | 194044 | Russia |
| Almazov Heart Center | Terminated | Saint Petersburg | 197341 | Russia |
| National University Hospital (NUH), | Terminated | Singapore | 119228 | Singapore |
| Jefe de Servicio de Cirugía Cardiovascular, Hospital Universitario La Princesa | Not yet recruiting | Madrid | 28006 | Spain |
|