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首页> 美国卫生研究院文献>Journal of Clinical and Translational Science >2034 Effect of balanced crystalloids on renal outcomes among critically ill adults does not differ from 0.9 saline across baseline risk of renal outcomes
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2034 Effect of balanced crystalloids on renal outcomes among critically ill adults does not differ from 0.9 saline across baseline risk of renal outcomes

机译：2034年平衡型晶体对重症成人肾脏结局的影响在基线肾脏结局风险中与0.9％生理盐水无差异

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OBJECTIVES/SPECIFIC AIMS: Traditional clinical trials typically enroll a homogenous population to test the efficacy of an intervention. Pragmatic trials deliberately enroll a more diverse population to enhance generalizability, but doing so may increase heterogeneity of treatment effect among subpopulations. For example, the effect of a treatment on an outcome may vary based on patients’ sex, comorbidities, or baseline risk of experiencing the outcome. We hypothesized that heterogeneity of treatment effect by baseline risk for the outcome could be demonstrated in a large pragmatic clinical trial. METHODS/STUDY POPULATION: We performed a prespecified secondary analysis of a recent pragmatic trial comparing balanced crystalloids Versus 0.9% saline among critically ill adults. The primary endpoint of the trial was major adverse kidney events within 30 days of ICU admission, censored at hospital discharge (MAKE30). MAKE30 is a composite outcome of all-cause mortality, new renal replacement therapy, or persistent renal dysfunction. Using a previously published model with high predictive accuracy for MAKE30 (area under the curve=0.903), we calculated the baseline risk of MAKE30 for all trial participants. We then developed a logistic regression model for MAKE30 with independent covariates of fluid group assignment, baseline risk of MAKE30 as a nonlinear continuous variable, and the interaction between group assignment and MAKE30 baseline risk. RESULTS/ANTICIPATED RESULTS: Among 15,802 patients from 5 intensive care units enrolled in the original trial, 126 had missing variables for predicted risk of MAKE30. Mean predicted risk of MAKE30 among all patients was 15.4%; median was 4.4% (interquartile range 2.2%–17.1%). Predicted risk of MAKE30 did not significantly differ between groups (p=0.61 by Mann-Whitney U-test). The incidence of MAKE30 in the trial was 14.9%, and the prediction model was well-calibrated overall (AUC=0.891). In a logistic regression model examining the interaction between group assignment and predicted risk of MAKE30, group assignment significantly affected MAKE30 (odds ratio saline:balanced 1.13, 95% CI: 1.02–1.27, p=0.02), but we observed no interaction between the effect of group assignment on MAKE30 and patients’ predicted risk of MAKE30 at baseline (p=0.66 for interaction term). DISCUSSION/SIGNIFICANCE OF IMPACT: In a large pragmatic trial demonstrating a significant difference in the primary outcome of MAKE30 between balanced crystalloids and saline, a previously published model accurately predicted MAKE30 using baseline factors. However, contrary to our hypothesis, the baseline risk of MAKE30 did not modify the effect of fluid group on the observed incidence of MAKE30. Our analysis could not account for unmeasured confounders and may be underpowered to detect a significant interaction. Our findings suggest that the impact of balanced crystalloids versus normal saline on renal outcomes in critically patients is consistent across all levels of risk.
机译：目标/特定目的：传统的临床试验通常招募同质人群来测试干预措施的有效性。务实试验故意招募更多样化的人群以增强普遍性，但这样做可能会增加亚人群之间治疗效果的异质性。例如，治疗对结果的影响可能会因患者的性别，合并症或经历结果的基线风险而异。我们假设，在一项大型的实用临床试验中可以证明以基线风险为结果的治疗效果的异质性。方法/研究人群：我们对近期的一项实用研究进行了预先指定的次要分析，该研究比较了危重成年人中平衡晶体与0.9％盐水的平衡。该试验的主要终点是入院30天内发生的重大肾脏不良事件，并在出院时进行了检查（MAKE30）。 MAKE30是全因死亡率，新的肾脏替代疗法或持续性肾功能不全的综合结果。使用先前发布的对MAKE30具有较高预测准确性的模型（曲线下面积= 0.903），我们计算了所有试验参与者的MAKE30基线风险。然后，我们针对流体组分配的独立协变量，作为非线性连续变量的MAKE30的基线风险以及组分配与MAKE30基线风险之间的相互作用，开发了MAKE30的逻辑回归模型。结果/预期结果：在原始试验的5个重症监护病房中，有15802名患者参加了研究，其中126名患者缺少预测MAKE30风险的变量。所有患者中MAKE30的平均预测风险为15.4％；中位数为4.4％（四分位数范围为2.2％-17.1％）。各组之间MAKE30的预测风险无显着差异（Mann-Whitney U检验p = 0.61）。该试验中MAKE30的发生率为14.9％，并且预测模型总体上得到了很好的校准（AUC = 0.891）。在检验组分配和预测的MAKE30风险之间的相互作用的逻辑回归模型中，组分配显着影响MAKE30（食盐水比率：平衡的1.13，95％CI：1.02-1.27，p = 0.02），但我们观察到组之间没有相互作用。分组对MAKE30的影响以及患者在基线时预测MAKE30的风险（交互作用项p = 0.66）。讨论/意义的影响：在一项大型的务实试验中，表明平衡的晶体和盐水之间MAKE30的主要结果存在显着差异，以前发表的模型使用基线因子准确地预测了MAKE30。但是，与我们的假设相反，MAKE30的基线风险并未改变液组对观察到的MAKE30发生率的影响。我们的分析无法说明无法衡量的混杂因素，因此可能不足以检测重大的相互作用。我们的研究结果表明，平衡的晶体与生理盐水对危重患者肾脏结局的影响在所有风险水平上均一致。

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