Department of Critical Care, Belfast Health and Social Care Trust, Belfast, UK.
Wellcome-Wolfson Institute for Experimental Medicine, Queen's University of Belfast, Lisburn Road, Belfast, BT9 7BL, UK.
Intensive Care Med. 2022 Feb;48(2):190-200. doi: 10.1007/s00134-021-06596-8. Epub 2021 Dec 16.
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.
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.
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.
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.
液体超负荷在危重病中很常见，并且与死亡率有关。本研究旨在探讨一项随机试验的可行性，该试验比较了在危重病中采用保守的液体管理和再复苏（使用利尿剂或超滤主动清除积聚的液体）与常规治疗的效果。
这是一项开放标签、平行组、分配隐藏的随机临床可行性试验。在入住重症监护病房（ICU）后 24-48 小时内，纳入预计需要 ICU 护理超过下一个日历日的机械通气成年患者。患者被随机分配到两阶段液体策略组或常规治疗组。两阶段液体策略组包括保守的液体管理，如果存在液体超负荷，则采用主动再复苏；常规治疗组则采用常规治疗。主要终点是研究第 3 天开始前 24 小时的液体平衡。次要终点包括累积液体平衡、死亡率和机械通气时间。
共纳入 180 例患者。在撤回 1 例患者后，将 89 例被分配到干预组的患者与 90 例被分配到常规治疗组的患者进行比较。干预组（-840 ± 1746 毫升）在研究第 3 天前 24 小时的平均液体平衡量低于常规治疗组（+130 ± 1401 毫升；P<0.01）。在第 3 天和第 5 天，干预组的累积液体平衡量较低。总体而言，两组的临床结局无显著差异，但 30 天死亡率的点估计值有利于常规治疗组[干预组：90 例患者中有 19 例（21.6%）；常规治疗组：89 例患者中有 14 例（15.6%），P=0.32]。基线时两组间存在不平衡，且统计效能不足限制了对临床结局的解释。
采用保守的液体管理和主动再复苏策略是可行的，与常规治疗相比可减少液体平衡，并可能带来益处或危害。鉴于当代临床实践中存在广泛的差异，需要进行大型、充分有效的试验，以评估在危重病患者中采用保守的液体策略的临床效果。
