背景:肺移植是治疗终末期肺病的唯一选择。尽管有所改进,在LTx中,原发性移植物功能障碍(PGD)仍然是早期死亡的主要原因,并导致慢性肺同种异体移植物功能障碍,肺移植后晚期死亡率的主要因素。原发性移植物功能障碍PGD在最初的72小时内发展并损害肺的氧合能力,测量为氧气的分压/吸入氧气的分数(P/F比)。因此,增加P/F比率是关键的并且对存活率具有直接影响。PGD普遍缺乏有效的治疗方法。当移植的肺不被受体的免疫系统接受时,全身性炎症反应开始时,细胞因子在启动中起关键作用,放大和维持导致PGD的炎症。细胞因子过滤可以从循环中去除这些细胞因子,从而减少炎症。然而,PGD缺乏治疗。在概念验证的临床前猪肺移植模型中,细胞因子过滤改善氧合并降低PGD。在一项可行性研究中,我们成功地用细胞因子过滤(NCT05242289)治疗了肺移植LTx患者。
目的:本临床试验的目的是证明细胞因子过滤在改善肺移植结局方面的优越性,基于它对氧合比的影响,炎症标志物的血浆水平,PGD发生率和严重程度,肺功能,肾功能,生存,与没有细胞因子过滤的标准治疗相比,生活质量。
方法:本研究是一项瑞典国家介入随机对照研究,涉及116名患者。其主要目的是研究与肺移植结合使用时细胞因子过滤的潜在益处。具体来说,这项研究旨在确定是否应用细胞因子过滤,在肺移植手术后的最初24小时内给药12小时,可以改善患者的预后。该研究旨在评估患者康复和整体健康的各个方面,以确定这种干预对移植后过程的潜在积极影响。
结果:本研究的患者招募过程计划在开始就诊后开始,定于2023年8月28日举行。在这项研究中评估的主要结果指标是氧合比,该指标表示为患者在肺移植手术后72小时内达到的最高P/F(PaO2/FiO2)比。
结论:我们认为细胞因子过滤可以提高肺移植的总体结局。我们的假设表明肺移植结果和患者护理的潜在改善。
背景:Clinicaltrials.gov:NCT05526950。医疗产品代理,瑞典(Dnr5.1-2023-23105)。
BACKGROUND: Lung transplantation (LTx) is the only treatment option for end-stage lung disease. Despite improvements, primary graft dysfunction (PGD) remains the leading cause of early mortality and precipitates chronic lung allograft dysfunction, the main factor in late mortality after LTx. PGD develops within the first 72 hours and impairs the oxygenation capacity of the lung, measured as partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2). Increasing the PaO2/FiO2 ratio is thus critical and has an impact on survival. There is a general lack of effective treatments for PGD. When a transplanted lung is not accepted by the immune system in the recipient, a systemic inflammatory response starts where cytokines play a critical role in initiating, amplifying, and maintaining the inflammation leading to PGD. Cytokine filtration can remove these cytokines from the circulation, thus reducing inflammation. In a proof-of-concept preclinical porcine model of LTx, cytokine filtration improved oxygenation and decreased PGD. In a feasibility study, we successfully treated patients undergoing LTx with cytokine filtration (ClinicalTrials.gov; NCT05242289).
OBJECTIVE: The purpose of this clinical
trial is to demonstrate the superiority of cytokine filtration in improving LTx outcome, based on its effects on oxygenation ratio, plasma levels of inflammatory markers, PGD incidence and severity, lung function, kidney function, survival, and quality of life compared with standard treatment with no cytokine filtration.
METHODS: This
study is a Swedish national interventional randomized controlled
trial involving 116 patients. Its primary objective is to investigate the potential benefits of cytokine filtration when used in conjunction with LTx. Specifically, this
study aims to determine whether the application of cytokine filtration, administered for a duration of 12 hours within the initial 24 hours following a LTx procedure, can lead to improved patient outcomes. This study seeks to assess various aspects of patient recovery and overall health to ascertain the potential positive impact of this intervention on the posttransplantation course.
RESULTS: The process of patient recruitment for this
study is scheduled to commence subsequent to a site initiation visit, which was slated to take place on August 28, 2023. The primary outcome measure that will be assessed in this research endeavor is the oxygenation ratio, a metric denoted as the highest PaO2/FiO2 ratio achieved by patients within a 72-hour timeframe following their LTx procedure.
CONCLUSIONS: We propose that cytokine filtration could enhance the overall outcomes of LTx. Our hypothesis suggests potential improvements in LTx outcome and patient care.
BACKGROUND: ClinicalTrials.gov NCT05526950; https://www.clinicaltrials.gov/
study/NCT05526950.
UNASSIGNED: PRR1-10.2196/52553.