Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Aalborg, Denmark.
Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.
Acta Anaesthesiol Scand. 2020 Jul;64(6):847-856. doi: 10.1111/aas.13569. Epub 2020 Mar 4.
No solid evidence exists on optimal oxygenation targets in intensive care patients. The handling oxygenation targets in the intensive care unit (HOT-ICU) trial assesses the effects of a targeted arterial oxygen tension of 8 vs 12 kPa on 90-day mortality in acutely admitted adult patients with hypoxaemic respiratory failure. This article describes the detailed statistical analysis plan for the predefined outcomes and supplementary analyses in the HOT-ICU trial.
The trial will include 2928 patients to be able to detect or reject a true 20% relative risk reduction in the primary outcome of 90-day all-cause mortality with an α of 5% and a β of 10%. Analyses of the primary and secondary outcomes will be conducted according to the intention-to-treat principle and adjusted for stratification variables. The primary outcome and dichotomous secondary outcomes will be analysed using a generalised linear model with a log-link and binomial error distribution. For the primary outcome, a 95% confidence interval (CI) not including 1.00 for the risk ratio will be considered statistically significant. Continuous secondary outcomes will be analysed using a generalised linear model or nonparametric test. CIs adjusted for the multiple secondary outcomes not including the null effect will be considered statistically significant. One planned interim analysis has been conducted.
The HOT-ICU trial and the pre-planned statistical analyses are designed to minimise bias and produce high quality data on the effects of a lower vs a higher oxygenation target throughout ICU admission in acutely admitted adult patients with hypoxaemic respiratory failure.
ClinicalTrials.gov identifier: NCT03174002, date of registration: June 2, 2017. European clinical trials database, EudraCT number 2017-000632-34.
目前尚无关于重症监护患者最佳氧合目标的确凿证据。HOT-ICU 试验评估了目标动脉氧分压为 8kPa 与 12kPa 对急性低氧性呼吸衰竭成年患者 90 天死亡率的影响，该试验旨在处理重症监护病房（ICU）中的氧合目标。本文描述了 HOT-ICU 试验中预设结局和补充分析的详细统计分析计划。
该试验将纳入 2928 例患者，以便能够检测或拒绝 90 天全因死亡率的主要结局有 20%的真实相对风险降低，其 α 值为 5%，β 值为 10%。主要和次要结局的分析将根据意向治疗原则进行，并根据分层变量进行调整。主要结局和二分类次要结局将使用具有对数链接和二项误差分布的广义线性模型进行分析。对于主要结局，风险比的 95%置信区间（CI）不包括 1.00 将被认为具有统计学意义。连续次要结局将使用广义线性模型或非参数检验进行分析。对于不包括零效应的多个次要结局进行调整的 CI 将被认为具有统计学意义。已进行了一次计划中的中期分析。
HOT-ICU 试验和预先计划的统计分析旨在最大限度地减少偏倚，并在急性低氧性呼吸衰竭成年患者 ICU 入住期间产生低氧与高氧合目标效果的高质量数据。
ClinicalTrials.gov 标识符：NCT03174002，注册日期：2017 年 6 月 2 日。欧洲临床试验数据库，EudraCT 编号 2017-000632-34。
