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Recruiting Phase 2/3 NCT03050476

Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase

Phase 2/3 – combined trial
Conditions: Systemic Inflammation Cardiopulmonary-bypass

Sponsor: Alloksys Life Sciences B.V.

trial.available_in: БГ
Overview
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.
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.
Who can participate
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)
Locations 10
Australia (1)
Dept. Cardiothoracic Surgery , Monash Medical Centre
Clayton , Melbourne
TERMINATED
Belgium (1)
Department of Intensive Care, CHU Saint-Pierre, Université Libre de Bruxelles (ULB)
Brussels
NOT_YET_RECRUITING
Germany (1)
German Heart Centre Munich, Dept.Cardio-Vascular Surgery
Munich , Bavaria
NOT_YET_RECRUITING
Italy (1)
U.O.C. Cardiochirurgia e Trapianti di Cuore, Azienda Ospedaliera San Camillo Forlanini
Roma
NOT_YET_RECRUITING
Malaysia (1)
Institut Jantung Negara (IJN , Natl. Heart Inst.)
Kuala Lumpur
TERMINATED
Netherlands (1)
Dept. Cardiothoracic Surgery, Maastricht University Medical Centre
Maastricht , Limburg
SUSPENDED
Portugal (1)
Hospital de Santa Marta
Lisbon
NOT_YET_RECRUITING
Russia (1)
State Autonomous Healthcare Institution "Interregional Clinical Diagnostic Center"
Kazan'
TERMINATED
Singapore (1)
National University Hospital (NUH),
Singapore
TERMINATED
Spain (1)
Jefe de Servicio de Cirugía Cardiovascular, Hospital Universitario La Princesa
Madrid
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 2/3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
21 Years
Healthy volunteers
No
Start date
01.11.2017
Completion date
31.03.2026
Registry ID
NCT03050476
Source
anzctr
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