Purpose

Fluid overload is common in critical illness and is associated with mortality. This study investigated the feasibility of a randomised trial comparing conservative fluid administration and deresuscitation (active removal of accumulated fluid using diuretics or ultrafiltration) with usual care in critical illness.

Methods

Open-label, parallel-group, allocation-concealed randomised clinical feasibility trial. Mechanically ventilated adult patients expected to require critical care beyond the next calendar day were enrolled between 24 and 48 h following admission to the intensive care unit (ICU). Patients were randomised to either a 2-stage fluid strategy comprising conservative fluid administration and, if fluid overload was present, active deresuscitation, or usual care. The primary endpoint was fluid balance in the 24 h up to the start of study day 3. Secondary endpoints included cumulative fluid balance, mortality, and duration of mechanical ventilation.

Results

One hundred and eighty patients were randomised. After withdrawal of 1 patient, 89 patients assigned to the intervention were compared with 90 patients assigned to the usual care group. The mean plus standard deviation (SD) 24-h fluid balance up to study day 3 was lower in the intervention group (− 840 ± 1746 mL) than the usual care group (+ 130 ± 1401 mL; P < 0.01). Cumulative fluid balance was lower in the intervention group at days 3 and 5. Overall, clinical outcomes did not differ significantly between the two groups, although the point estimate for 30-day mortality favoured the usual care group [intervention arm: 19 of 90 (21.6%) versus usual care: 14 of 89 (15.6%), P = 0.32]. Baseline imbalances between groups and lack of statistical power limit interpretation of clinical outcomes.

Conclusions

A strategy of conservative fluid administration and active deresuscitation is feasible, reduces fluid balance compared with usual care, and may cause benefit or harm. In view of wide variations in contemporary clinical practice, large, adequately powered trials investigating the clinical effectiveness of conservative fluid strategies in critically ill patients are warranted.

中文翻译：

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与常规护理相比，危重病中保守输液和复苏的可行性：复苏后主动复苏的作用 - 2 (RADAR-2) 随机临床试验

目的

液体超负荷在危重疾病中很常见，并且与死亡率相关。本研究调查了一项随机试验的可行性，该试验将保守输液和复苏术（使用利尿剂或超滤主动去除积液）与危重疾病的常规护理进行比较。

方法

开放标签、平行组、分配隐藏的随机临床可行性试验。预计在下一个日历日之后需要重症监护的机械通气成年患者在入住重症监护病房 (ICU) 后 24 至 48 小时内入组。患者被随机分配接受两阶段液体策略，包括保守性液体给药，如果存在液体超负荷，则主动停止复苏或常规护理。主要终点是截至研究第 3 天开始的 24 小时内的液体平衡。次要终点包括累积液体平衡、死亡率和机械通气持续时间。

结果

一百八十名患者被随机分组​​。1 名患者退出后，将分配到干预组的 89 名患者与分配到常规护理组的 90 名患者进行比较。截至研究第 3 天的 24 小时液体平衡平均值加标准差 (SD) 干预组 (− 840 ± 1746 mL) 低于常规护理组 (+ 130 ± 1401 mL；P < 0.01 )  。干预组在第 3 天和第 5 天的累积体液平衡较低。总体而言，两组之间的临床结果没有显着差异，尽管 30 天死亡率的点估计有利于常规护理组 [干预组：90 人中的 19 人（ 21.6%）与常规护理相比：89 例中的 14 例（15.6%），P  = 0.32]。组间基线不平衡和缺乏统计功效限制了对临床结果的解释。

结论

保守输液和主动复苏的策略是可行的，与常规护理相比，会降低液体平衡，并且可能会带来益处或危害。鉴于当代临床实践的巨大差异，有必要进行大型、充分有力的试验来调查危重患者保守液体策略的临床有效性。