Using alkaline phosphatase to reduce inflammation after heart surgery
Preventing Oxidative Stress-induced Ischemic Injury- and Systemic Inflammation Complications During and After Invasive Cardiac Surgery With Alkaline Phosphatase (APPIRED III)
This study is testing if a treatment called alkaline phosphatase can help heart surgery patients avoid serious complications like kidney injury and other issues after their surgery.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1250 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Alloksys Life Sciences B.V. Industry-sponsored |
| Locations | 21 sites (Clayton, Melbourne and 20 other locations) |
| Trial ID | NCT03050476 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of alkaline phosphatase on patients undergoing cardiac surgery with cardiopulmonary bypass (CPB). It aims to demonstrate that alkaline phosphatase can reduce the incidence and severity of acute kidney injury (AKI) and other complications such as late extubation and gastrointestinal or neurological issues within a specified timeframe. Patients will be compared to a placebo group to assess the efficacy of the treatment. The study will include patients with a certain risk profile based on their surgical needs and health status.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for cardiac surgery requiring cardiopulmonary bypass with a moderate to high risk of complications.
Not a fit: Patients with chronic kidney disease, those on renal replacement therapy, or individuals with certain allergies or ongoing infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce complications and improve recovery outcomes for patients undergoing cardiac surgery.
How similar studies have performed: Previous studies have shown promising results with similar approaches, but this specific application of alkaline phosphatase is being tested in a novel context.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Clayton, Melbourne and 20 other locations
- Dept. Cardiothoracic Surgery , Monash Medical Centre — Clayton, Melbourne, Australia (Terminated)
- Division of Cardiac Surgery, Department of Surgery, LKH Medical University of Graz — Graz, Austria (Not_yet_recruiting)
- MedUniWien / AKH-Wien — Wien, Austria (Recruiting)
- Department of Intensive Care, CHU Saint-Pierre, Université Libre de Bruxelles (ULB) — Brussels, Belgium (Not_yet_recruiting)
- Department of Intensive Care, Hôpital Universitaire de Bruxelles (HUB) — Brussels, Belgium (Not_yet_recruiting)
- Hospital ZOL — Genk, Belgium (Suspended)
- Dept. of Anesthesia and Intensive Care, AZ Maria Middelares — Gent, Belgium (Recruiting)
- Jessa Ziekenhuis,Campus Virga Jesse — Hasselt, Belgium (Recruiting)
- German Heart Centre Munich, Dept.Cardio-Vascular Surgery — Munich, Bavaria, Germany (Not_yet_recruiting)
- Klinik für Herzchirurgie, Universitätsklinik — Leipzig, Germany (Suspended)
- U.O.C. Cardiochirurgia e Trapianti di Cuore, Azienda Ospedaliera San Camillo Forlanini — Roma, Italy (Not_yet_recruiting)
- Policlinico Gemelli, Institute Cardiology — Roma, Italy (Not_yet_recruiting)
- Institut Jantung Negara (IJN , Natl. Heart Inst.) — Kuala Lumpur, Malaysia (Terminated)
- Dept. Cardiothoracic Surgery, Maastricht University Medical Centre — Maastricht, Limburg, Netherlands (Suspended)
- Catharina Ziekenhuis, Cathreine R&D, Heartcentre — Eindhoven, Netherlands (Terminated)
- Hospital de Santa Marta — Lisboa, Portugal (Not_yet_recruiting)
- State Autonomous Healthcare Institution "Interregional Clinical Diagnostic Center" — Kazan, Russian Federation (Terminated)
- Federal State Budgetary Military Educational Institution of the Higher Education — Saint Petersburg, Russian Federation (Terminated)
- Almazov Heart Center — St Petersburg, Russian Federation (Terminated)
- National University Hospital (NUH), — Singapore, Singapore (Terminated)
- Jefe de Servicio de Cirugía Cardiovascular, Hospital Universitario La Princesa — Madrid, Spain (Not_yet_recruiting)
Study contacts
- Principal investigator: Dominik Wiedemann, Prof.Dr. — Universitätsklinikum St. Pölten, Austria
- Study coordinator: Ruud Brands, PhD
- Email: ruud@alloksys.com
- Phone: +31 647 228 395
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.