Език: EN EN
← Назад към резултатите
Набира участници Фаза 2/3 NCT03050476

Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase

Фаза 2/3 – комбинирано изпитване
Заболявания: Systemic Inflammation Cardiopulmonary-bypass

Спонсор: Alloksys Life Sciences B.V.

Налично на: БГ
Обобщение
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.
Описание
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.
Кой може да участва
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)
Места на провеждане 10
Австралия (1)
Dept. Cardiothoracic Surgery , Monash Medical Centre
Clayton , Melbourne
TERMINATED
Белгия (1)
Department of Intensive Care, CHU Saint-Pierre, Université Libre de Bruxelles (ULB)
Brussels
NOT_YET_RECRUITING
Германия (1)
German Heart Centre Munich, Dept.Cardio-Vascular Surgery
Munich , Bavaria
NOT_YET_RECRUITING
Италия (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
Нидерландия (1)
Dept. Cardiothoracic Surgery, Maastricht University Medical Centre
Maastricht , Limburg
SUSPENDED
Португалия (1)
Hospital de Santa Marta
Lisbon
NOT_YET_RECRUITING
Russia (1)
State Autonomous Healthcare Institution "Interregional Clinical Diagnostic Center"
Kazan'
TERMINATED
Сингапур (1)
National University Hospital (NUH),
Singapore
TERMINATED
Испания (1)
Jefe de Servicio de Cirugía Cardiovascular, Hospital Universitario La Princesa
Madrid
NOT_YET_RECRUITING
Технически детайли
Статус
Набира участници
Фаза
Фаза 2/3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
21 Years
Здрави доброволци
Не
Начална дата
01.11.2017
Крайна дата
31.03.2026
Регистрационен номер
NCT03050476
Източник
anzctr
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.