Keratinocyte growth factor in acute lung injury to reduce pulmonary dysfunction--a randomised placebo-controlled trial (KARE): study protocol.
Keratinocyte growth factor in acute lung injury to reduce pulmonary dysfunction--a randomised placebo-controlled trial (KARE): study protocol.
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DOI：
10.1186/1745-6215-14-51
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发表时间：
2013-02-18
期刊：
影响因子：
2.5
通讯作者：
McAuley DF
中科院分区：
文献类型：
--
作者：
Cross LJ;O'Kane CM;McDowell C;Elborn JJ;Matthay MA;McAuley DF
急性肺损伤是一种常见的、毁灭性的临床综合征，与高死亡率和发病率相关，目前尚无经过证实的治疗干预策略来改善患者结局。本研究的目的是测试角质细胞生长因子对急性肺损伤患者的氧合和急性炎症、肺上皮和内皮功能、蛋白酶：抗蛋白酶平衡以及肺细胞外基质降解和周转的生物学指标的潜在治疗作用。这将是一项前瞻性、随机、双盲、分配隐藏、安慰剂对照、II期、多中心试验。将根据是否存在需要血管加压药的重度脓毒症对随机化进行分层。ICU中符合美欧共识会议急性肺损伤定义的患者将以1：1的比例随机接受角质细胞生长因子（帕利弗明，60 μg/kg）或安慰剂（0.9%氯化钠溶液）静脉推注，每日一次，最多持续6天。本临床研究的主要终点是评价帕利弗明改善第7天氧合指数或患者中止研究前末次可用氧合指数的疗效。已制定正式的统计分析计划。将在意向治疗基础上进行分析。计划在试验结束时进行单次分析。P = 0.05将被视为具有统计学显著性，所有检验均为双侧检验。对于连续分布的结局，将使用独立样本t检验、方差分析和协方差分析（将变量转换为正态或非参数等效值）检验组间差异。将根据试验报告统一标准（Consort 2010指南）报告试验。http：//ISRCTN95690673
Acute lung injury is a common, devastating clinical syndrome associated with substantial mortality and morbidity with currently no proven therapeutic interventional strategy to improve patient outcomes. The objectives of this study are to test the potential therapeutic effects of keratinocyte growth factor for patients with acute lung injury on oxygenation and biological indicators of acute inflammation, lung epithelial and endothelial function, protease:antiprotease balance, and lung extracellular matrix degradation and turnover. This will be a prospective, randomised, double-blind, allocation-concealed, placebo-controlled, phase 2, multicentre trial. Randomisation will be stratified by presence of severe sepsis requiring vasopressors. Patients in an ICU fulfilling the American–European Consensus Conference Definition of acute lung injury will be randomised in a 1:1 ratio to receive an intravenous bolus of either keratinocyte growth factor (palifermin, 60 μg/kg) or placebo (0.9% sodium chloride solution) daily for a maximum of 6 days. The primary endpoint of this clinical study is to evaluate the efficacy of palifermin to improve the oxygenation index at day 7 or the last available oxygenation index prior to patient discontinuation from the study. A formal statistical analysis plan has been constructed. Analyses will be carried out on an intention-to-treat basis. A single analysis is planned at the end of the trial. P = 0.05 will be considered statistically significant and all tests will be two-sided. For continuously distributed outcomes, differences between groups will be tested using independent-sample t tests, analysis of variance and analysis of covariance with transformation of variables to normality or nonparametric equivalents. The trial will be reported in line with the Consolidated Standards of Reporting Trials (Consort 2010 guidelines). http://ISRCTN95690673
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作者：
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影响因子：
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