Objective

The Calcium for Out-of-hospital Cardiac Arrest (COCA) trial was a randomized, placebo-controlled, double-blind trial of calcium for out-of-hospital cardiac arrest. The primary and secondary outcomes have been reported previously. This article describes the long-term outcomes of the trial.

Methods

Patients aged ≥18 years were included if they had a non-traumatic out-of-hospital cardiac arrest during which they received adrenaline. The trial drug consisted of calcium chloride (5 mmol) or saline placebo given after the first dose of adrenaline and again after the second dose of adrenaline for a maximum of two doses. This article presents pre-specified analyses of 6-month and 1-year outcomes for survival, survival with a favorable neurological outcome (modified Rankin Scale of 3 or less), and health-related quality of life.

Results

A total of 391 patients were analyzed. At 1 year, 9 patients (4.7%) were alive in the calcium group while 18 (9.1%) were alive in the placebo group (risk ratio 0.51; 95% confidence interval 0.24, 1.09). At 1 year, 7 patients (3.6%) were alive with a favorable neurological outcome in the calcium group while 17 (8.6%) were alive with a favorable neurological outcome in the placebo group (risk ratio 0.42; 95% confidence interval 0.18, 0.97). Outcomes for health-related quality of life likewise suggested harm of calcium but results were imprecise with wide confidence intervals.

Conclusions

Effect estimates remained constant over time suggesting harm of calcium but with wide confidence intervals. The results do not support calcium administration during out-of-hospital cardiac arrest.

Trial registration

ClinicalTrials.gov-number, NCT04153435.

中文翻译：

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钙与安慰剂对院外心脏骤停患者长期结局的影响

客观的

用于院外心脏骤停的钙 (COCA) 试验是一项随机、安慰剂对照、双盲的钙用于院外心脏骤停的试验。主要和次要结局之前已经报道过。本文描述了试验的长期结果。

方法

年龄≥18 岁的患者在接受肾上腺素治疗期间发生非创伤性院外心脏骤停。试验药物包括氯化钙（5 mmol）或盐水安慰剂，在第一剂肾上腺素后和第二剂肾上腺素后再次给药，最多两剂。本文介绍了对 6 个月和 1 年生存结果、具有良好神经系统结果（改良 Rankin 量表为 3 或更少）的生存以及与健康相关的生活质量的预先指定分析。

结果

共分析了 391 名患者。1 年时，钙组有 9 名患者 (4.7%) 存活，而安慰剂组有 18 名患者 (9.1%) 存活（风险比 0.51；95% 置信区间 0.24, 1.09）。1 年时，钙组有 7 名患者 (3.6%) 存活，神经系统预后良好，而安慰剂组 17 名患者 (8.6%) 存活，神经系统预后良好（风险比 0.42；95% 置信区间 0.18, 0.97 ）。与健康相关的生活质量的结果同样表明钙的危害，但结果不精确，置信区间很宽。

结论

随着时间的推移，效果估计值保持不变，表明钙的危害，但置信区间较宽。结果不支持在院外心脏骤停期间给予钙剂。

试用注册

ClinicalTrials.gov 号，NCT04153435。