对SODa-BIC随机临床试验使用多个层级复合结局进行的二次分析。
完整摘要 · 中文译文
背景：ICU中碳酸氢钠治疗代谢性酸中毒（SODa-BIC）试验评估了碳酸氢钠对重症代谢性酸中毒患者30天主要不良肾脏事件（MAKE30）的影响。尽管该试验显示主要结局无显著差异，但各组成部分显示出不同大小和方向的效果；我们采用不同的分级结局对SODa-BIC试验进行了一项探索性分析，以更好地理解碳酸氢钠的潜在治疗效果。 方法：对SODa-BIC试验的事后分析。纳入SODa-BIC试验的所有患者均符合条件。主要结局为胜率比分析，其层级包括死亡、肾脏替代治疗需求、持续性肾功能不全和住院时长。进行了多项敏感性分析和亚组分析。 结果：主要分析纳入了来自488例患者的59，250对比较。与SODa-BIC分析一致，未观察到碳酸氢钠治疗效果的总体证据，胜率比为0.97（95%CI 0.79 - 1.19），结局排序可取性概率为0.49（95%CI 0.45 - 0.54）。大多数成对比较由死亡和住院时长决定。在按急性肾损伤和酸血症严重程度划分的亚组中，观察到显著的治疗效果修饰证据。 结论：在这项对SODa-BIC试验的事后分析中，使用分级复合结局并未改变中性的总体解释，但提示碳酸氢钠的效果可能随急性肾损伤和酸血症严重程度的不同而变化，值得进一步研究。 对原始试验的解释。然而，本分析为原发结局各组成部分的相对贡献提供了额外见解。
完整摘要 · 英文原文
BACKGROUND: The Sodium Bicarbonate for Metabolic Acidosis in the ICU (SODa-BIC) trial assessed the effect of sodium bicarbonate on Major Adverse Kidney Events at 30 days (MAKE30) in critically ill patients with metabolic acidosis. Although the trial demonstrated no significant difference in the primary outcome, the individual components showed differing magnitudes and directions of effect; we undertook an exploratory analysis of the SODa-BIC trial using different hierarchical outcomes to better understand potential treatment effects of sodium bicarbonate. METHODS: Post-hoc analysis of the SODa-BIC trial. All patients included in the SODa-BIC trial were eligible. The primary outcome was a win ratio analysis with a hierarchy consisting of death, requirement for renal replacement therapy, persistent renal dysfunction, and hospital length of stay. Several sensitivity and subgroup analyses were conducted. RESULTS: The primary analysis resulted in 59,250 pairs from 488 patients. Consistent with the SODa-BIC analysis, there was no overall evidence of a treatment effect of sodium bicarbonate, with a win ratio of 0.97 (95%CI 0.79 - 1.19) and a Desirability of Outcome Ranking probability of 0.49 (95%CI 0.45 - 0.54). A majority of pairwise comparisons were resolved by mortality and hospital length of stay. Evidence of significant treatment effect modification was observed across subgroups defined by acute kidney injury and severity of acidemia. CONCLUSION: In this post-hoc analysis of the SODa-BIC trial, the use of hierarchical composite outcomes did not alter the neutral overall interpretation of the original trial. However, this analysis provides additional insight into the relative contribution of individual components of the primary outcome.