Clinical trial NCT03050476: Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase
Official title: Preventing Oxidative Stress-induced Ischemic Injury- and Systemic Inflammation Complications During and After Invasive Cardiac Surgery With Alkaline Phosphatase (APPIRED III)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Systemic Inflammation
Cardiopulmonary-bypass
Keywords: side-effects
heart-lung machine
alkaline phosphatase
Lead sponsor: Alloksys Life Sciences B.V.
Sponsor class: INDUSTRY
Collaborators: name: Aix Scientifics
First posted: 2017-02-13
Enrollment: 1250
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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)

Primary outcomes:
measure: Number of patients with acute kidney injury
timeFrame: 90 days
measure: reach haemodynamic stability
timeFrame: 7 days
Secondary outcomes:
measure: cost-related outcome
timeFrame: 30 days
measure: levels of a set of inflammatory markers
timeFrame: 4 days
Other outcomes:
Locations:
city: Clayton
country: Australia
facility: Dept. Cardiothoracic Surgery , Monash Medical Centre
state: Melbourne
city: Graz
country: Austria
facility: Division of Cardiac Surgery, Department of Surgery, LKH Medical University of Graz
city: Wien
country: Austria
facility: MedUniWien / AKH-Wien
city: Brussels
country: Belgium
facility: Department of Intensive Care, CHU Saint-Pierre, Université Libre de Bruxelles (ULB)
city: Brussels
country: Belgium
facility: Department of Intensive Care, Hôpital Universitaire de Bruxelles (HUB)
city: Genk
country: Belgium
facility: Hospital ZOL
city: Gent
country: Belgium
facility: Dept. of Anesthesia and Intensive Care, AZ Maria Middelares
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis,Campus Virga Jesse
city: Munich
country: Germany
facility: German Heart Centre Munich, Dept.Cardio-Vascular Surgery
state: Bavaria
city: Leipzig
country: Germany
facility: Klinik für Herzchirurgie, Universitätsklinik
city: Roma
country: Italy
facility: U.O.C. Cardiochirurgia e Trapianti di Cuore, Azienda Ospedaliera San Camillo Forlanini
city: Roma
country: Italy
facility: Policlinico Gemelli, Institute Cardiology
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara (IJN , Natl. Heart Inst.)
city: Maastricht
country: Netherlands
facility: Dept. Cardiothoracic Surgery, Maastricht University Medical Centre
state: Limburg
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis, Cathreine R&D, Heartcentre
city: Lisboa
country: Portugal
facility: Hospital de Santa Marta
city: Kazan
country: Russian Federation
facility: State Autonomous Healthcare Institution "Interregional Clinical Diagnostic Center"
city: Saint Petersburg
country: Russian Federation
facility: Federal State Budgetary Military Educational Institution of the Higher Education
city: St Petersburg
country: Russian Federation
facility: Almazov Heart Center
city: Singapore
country: Singapore
facility: National University Hospital (NUH),
city: Madrid
country: Spain
facility: Jefe de Servicio de Cirugía Cardiovascular, Hospital Universitario La Princesa
Study officials:
affiliation: Alloksys Life Sciences BV . President
name: Ruud Brands, PhD
role: STUDY_CHAIR
affiliation: Universitätsklinikum St. Pölten, Austria
name: Dominik Wiedemann, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References: