Cytokine Filtration in Lung Transplantation: A Swedish National Study (GLUSorb)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Device: CytoSorb.
- Кому может быть актуально
- Состояния в реестре: Lung Transplant Failure, Lung Transplant; Complications. Базовые параметры: 18 лет — 80 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Швеция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Cytokine Filtration in Lung Transplantation - a Randomised, Controlled, Multicentre Clinical Trial (GLUSorb)
Обзор
Lung transplantation (LTx) remains the gold standard for treating patients with irreversible end-stage pulmonary disease. Of the major organs transplanted, survival in LTx recipients remains the lowest (mean 5 years). Despite improvements, primary graft dysfunction (PGD), as defined by respiratory insufficiency and edema up to 72 hours post LTx, remains the leading cause of early mortality and contributes to the development of chronic lung allograft dysfunction (CLAD) which is the leading cause of late mortality. PGD develops within the first 72 hours after LTx. The development of CLAD increases quickly with cumulative incidence of 40-80 % within the first 3-5 years. There is a general lack of efficient treatments for PGD and CLAD. Prevention of PGD is therefore of crucial importance and has a direct impact on survival. The present study is a randomized controlled study which aims to compare patients undergoing LTx with and without the utilization of cytokine adsorption.
Подробное описание
Early intolerance to the newly transplanted lung starts at the time of transplantation and results in PGD driven by an intense inflammatory response. Cytokines play a critical role as signaling molecules that initiate, amplify, and maintain inflammatory responses both locally and systemically. The use of cytokine filtration devices to target middle- and low-molecular weight molecules has been shown to reduce levels of a diverse number of cytokines. These results have been demonstrated in the in vitro reduction of pathogen-associated molecular pattern molecules (PAMPS) and damage associated molecular patterns (DAMPS) as well as in in vivo studies involving orthotopic heart transplantation and kidney transplantation. Cytokine adsorption has been used successfully in clinical applications to both heart and kidney transplantation.
The present study is a randomized controlled study which aims to collect preliminary data on the efficacy of a medical device through the comparison of patients undergoing LTx with and without cytokine adsorption.
Вмешательства
- Устройство Device: CytoSorb
Medical device used hemoperfusion and cytokine adsorption in conjunction with lung transplantation.
Первичные конечные точки
- To determine whether cytokine reduction by cytokine filtration leads to improved oxygenation in patients undergoing lung transplantation. [Срок оценки: First 72 hours after lung transplantation]
- To determine whether cytokine reduction by cytokine filtration leads to improved oxygenation in patients undergoing lung transplantation. Oxygenation at 24 hours [Срок оценки: 24 hours after lung transplantation]
- To determine whether cytokine reduction by cytokine filtration leads to improved oxygenation in patients undergoing lung transplantation. Oxygenation at 48 hours [Срок оценки: 48 hours after lung transplantation]
- To determine whether cytokine reduction by cytokine filtration leads to improved oxygenation in patients undergoing lung transplantation. Oxygenation at 72 hours [Срок оценки: 72 hours after lung transplantation]
Вторичные конечные точки (12)
- To determine whether cytokine reduction by cytokine filtration improves levels of plasma inflammatory markers (including cytokines) in patients undergoing lung transplantation. [Срок оценки: 0-72 hours (0-3 days) after lung transplantation]
- To determine whether cytokine reduction by cytokine filtration decreases lung infiltrates and oedema in patients undergoing lung transplantation [Срок оценки: 0-72 hours (0-3 days) after lung transplantation]
- To determine whether cytokine reduction by cytokine filtration improves arterial blood gas measures in patients undergoing lung transplantation [Срок оценки: 0-72 hours (0-3 days) after lung transplantation]
- To determine whether cytokine reduction by cytokine filtration decreases severity of primary graft dysfunction (PGD) in patients undergoing lung transplantation [Срок оценки: 0-72 hours (0-3 days) after lung transplantation]
- To determine whether cytokine reduction by cytokine filtration decreases incidence of primary graft dysfunction (PGD) in patients undergoing lung transplantation [Срок оценки: 0-72 hours (0-3 days) after lung transplantation]
- To determine whether cytokine reduction by cytokine filtration decreases need for norepinephrine in patients undergoing lung transplantation [Срок оценки: 0-72 hours (0-3 days) after lung transplantation]
- To determine whether cytokine reduction by cytokine filtration decreases mortality in patients undergoing lung transplantation [Срок оценки: First 4 years]
- To determine whether cytokine reduction by cytokine filtration improves diffusion capacity of the lungs (DLCO) in patients undergoing lung transplantation [Срок оценки: First 4 years]
- To determine whether cytokine reduction by cytokine filtration improves forced expiratory volume (FEV1), forced vital capacity (FVC), and total lung capacity in patients undergoing lung transplantation [Срок оценки: First 4 years]
- To determine whether cytokine reduction by cytokine filtration improves occurrence of any acute rejection episodes in patients undergoing lung transplantation [Срок оценки: First 4 years]
- To determine whether cytokine reduction by cytokine filtration improves Chest CT in patients undergoing lung transplantation [Срок оценки: First 4 years]
- To determine whether cytokine reduction by cytokine filtration improves presence of any CLAD in patients undergoing lung transplantation [Срок оценки: First 4 years]
Критерии участия
Критерии включения
- Eligibility to undergo double lung transplantation at either trial site
Критерии исключения
- Age <18 years
- Previous organ transplantation
- Presence of any conditions at the time of surgery that require immunosuppressive therapy. Immunosuppressive therapy is defined as:
- Cyclosporine, Tacrolimus, Everolimus, or Sirolimus, minimum 1 month of treatment prior to transplantation and active treatment at the time of transplantation.
- Any form of antibody-based treatment that is known for having an immunomodulatory effect taken up to 1 week before transplantation.
- Non-consent
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Швеция · 1 центр
- Sandra Lindstedt — Lund
Публикации
- Ghaidan H, Stenlo M, Niroomand A, Mittendorfer M, Hirdman G, Gvazava N, Edstrom D, Silva IAN, Broberg E, Hallgren O, Olm F, Wagner DE, Pierre L, Hyllen S, Lindstedt S. Reduction of primary graft dysfunction using cytokine adsorption during organ preservation and after lung transplantation. Nat Commun. 2022 Jul 26;13(1):4173. doi: 10.1038/s41467-022-31811-5. PMID 35882835
- Niroomand A, Qvarnstrom S, Stenlo M, Malmsjo M, Ingemansson R, Hyllen S, Lindstedt S. The role of mechanical ventilation in primary graft dysfunction in the postoperative lung transplant recipient: A single center study and literature review. Acta Anaesthesiol Scand. 2022 Apr;66(4):483-496. doi: 10.1111/aas.14025. Epub 2022 Jan 27. PMID 35014027
- Niroomand A, Hirdman G, Olm F, Lindstedt S. Current Status and Future Perspectives on Machine Perfusion: A Treatment Platform to Restore and Regenerate Injured Lungs Using Cell and Cytokine Adsorption Therapy. Cells. 2021 Dec 29;11(1):91. doi: 10.3390/cells11010091. PMID 35011653
- Lindstedt S, Niroomand A, Mittendorfer M, Hirdman G, Hyllen S, Pierre L, Olm F. Nothing but NETs: Cytokine adsorption correlates with lower circulating nucleosomes and is associated with decreased primary graft dysfunction. J Heart Lung Transplant. 2023 Oct;42(10):1358-1362. doi: 10.1016/j.healun.2023.06.011. Epub 2023 Jun 20. PMID 37348689
- Lindstedt S, Silverborn M, Lannemyr L, Pierre L, Larsson H, Grins E, Hyllen S, Dellgren G, Magnusson J. Design and Rationale of Cytokine Filtration in Lung Transplantation (GLUSorb): Protocol for a Multicenter Clinical Randomized Controlled Trial. JMIR Res Protoc. 2023 Dec 13;12:e52553. doi: 10.2196/52553. PMID 37855706
Идентификаторы
NCT: NCT05526950 · GLUSorb