Effects of an early restrictive versus liberal fluid strategy on long-term patient-centered outcomes in sepsis-induced hypotension: an open-label, randomized controlled trial.

Background

To assess the effect of an early restrictive or liberal fluid resuscitation strategy on long-term functional outcomes in patients with sepsis-induced hypotension.

评估早期限制性或宽松性液体复苏策略对脓毒症诱导性低血压患者长期功能结果的影响。

Methods

SHAMROC (Sepsis-induced Hypotension: Assessing effect of Method of Resuscitation On Patient-centered Outcomes) prospectively assessed the impact of random assignment to a restrictive or liberal fluid resuscitation strategy for sepsis-induced hypotension outcomes at 6 and 12 months after randomization in the NIH NHLBI PETAL Network's CLOVERS trial (NCT03434028).

SHAMROC（脓毒性休克诱导的低血压：评估复苏方法对患者中心结果的影响）前瞻性地评估了在 NIH NHLBI PETAL 网络的 CLOVERS 试验中（NCT03434028），随机分配到限制性或宽松性液体复苏策略对于脓毒性休克引起的低血压患者在随机分组后6个月和12个月的患者中心结果的影响。

The pre-specified analyses used trimmed means at 50% to prevent informative censoring of deceased patients.

预先设定的分析使用了50%的修剪均值以防止对已故患者的有信息性截断。

measurements_and_main_results

Of the 1563 participants included in the CLOVERS trial, 898 (57%) were included in the SHAMROC trial. As 196 were lost to follow-up, 702 participants were analyzed at 6 months (431 survivors and 271 non-survivors).

在CLOVERS试验中，共有1563名参与者，其中898名（占57%）被纳入SHAMROC试验。由于有196名参与者失访，因此在6个月时对702名参与者进行了分析（431名幸存者和271名非幸存者）。

Baseline characteristics were similar between the groups.

两组的基线特征相似。

At 6 months, no group differences were observed in cognitive function (restrictive versus liberal; trimmed mean difference in Montreal Cognitive Assessment-Blind Score, 0.11, 95% CI -1.44-1.70), executive function (trimmed mean difference in Hayling Sentence Completion Test, 0.38, 95% CI -0.97-1.76), disability status (trimmed mean difference in Activity of Daily Living Score, 0.03, 95% CI -0.84-0.90), mobility (trimmed mean difference in PROMIS Mobility Score, 0.72, 95% CI -2.20-3.64), and health-related quality of life (trimmed mean difference in EQ-5D-5L, -0.01, 95% CI -0.07-0.06).

在6个月时，两组在认知功能（限制性与自由性；蒙特利尔认知评估-盲法评分的修剪均值差异为0.11，95%置信区间为-1.44至1.70）、执行功能（Hayling句子完成测试的修剪均值差异为0.38，95%置信区间为-0.97至1.76）、残疾状态（日常生活活动评分的修剪均值差异为0.03，95%置信区间为-0.84至0.90）、移动能力（PROMIS移动能力评分的修剪均值差异为0.72，95%置信区间为-2.20至3.64）以及与健康相关的生活质量（EQ-5D-5L评分的修剪均值差异为-0.01，95%置信区间为-0.07至0.06）方面均未观察到差异。

Outcomes also did not differ at 12 months.

在12个月时，结果也没有差异。

Conclusions

In this long-term follow-up of a randomized controlled trialof patients with sepsis-induced hypotension, the restrictive fluid strategy used in this study resulted in similar cognitive and physical function at 6 and 12 months, compared to a liberal fluid strategy.

在这项针对脓毒症诱导性低血压患者的随机对照试验的长期随访中，本研究中使用的限制性液体策略在6个月和12个月时，与宽松液体策略相比，认知和身体功能相似。