Background

More than 50% of patients have a major complication after emergency gastrointestinal surgery. Intravenous (i.v.) fluid therapy is a life-saving part of treatment, but evidence to guide what i.v. fluid strategy results in the best outcome is lacking. We hypothesised that goal-directed fluid therapy during surgery (GDT group) reduces the risk of major complications or death in patients undergoing major emergency gastrointestinal surgery compared with standard i.v. fluid therapy (STD group).

Methods

In a randomised, assessor-blinded, two-arm, multicentre trial, we included 312 adult patients with gastrointestinal obstruction or perforation. Patients in the GDT group received i.v. fluid to near-maximal stroke volume. Patients in the STD group received i.v. fluid following best clinical practice. Postoperative target was 0–2 L fluid balance. The primary outcome was a composite of major complications or death within 90 days. Secondary outcomes were time in intensive care, time on ventilator, time in dialysis, hospital stay, and minor complications.

Results

In a modified intention-to-treat analysis, we found no difference in the primary outcome between groups: 45 (30%) (GDT group) vs 39 (25%) (STD group) (odds ratio=1.24; 95% confidence interval, 0.75–2.05; P=0.40). Hospital stay was longer in the GDT group: median (inter-quartile range), 7 (4–12) vs 6 days (4–8.5) (P=0.04); no other differences were found.

Conclusion

Compared with pressure-guided i.v. fluid therapy (STD group), flow-guided fluid therapy to near-maximal stroke volume (GDT group) did not improve the outcome after surgery for bowel obstruction or gastrointestinal perforation but may have prolonged hospital stay.

Clinical trial registration

EudraCT number 2015-000563-14; the Danish Scientific Ethics Committee and the Danish Data Protection Agency (REG-18-2015).

中文翻译：

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急诊腹部手术中的目标导向液体治疗：一项随机多中心试验

背景

超过 50% 的患者在紧急胃肠道手术后出现严重并发症。静脉内 (iv) 液体治疗是治疗中挽救生命的一部分，但缺乏指导哪种静脉输液策略产生最佳结果的证据。我们假设与标准静脉输液治疗（STD 组）相比，手术期间目标导向的液体治疗（GDT 组）可降低接受主要紧急胃肠道手术的患者发生严重并发症或死亡的风险。

方法

在一项随机、评估者盲、双臂、多中心试验中，我们纳入了 312 名患有胃肠道梗阻或穿孔的成年患者。GDT 组患者接受静脉输液至接近最大每搏输出量。STD 组患者按照最佳临床实践接受静脉输液。术后目标是 0-2 L 液体平衡。主要结果是 90 天内主要并发症或死亡的复合。次要结局是重症监护时间、呼吸机时间、透析时间、住院时间和轻微并发症。

结果

在改良的意向治疗分析中，我们发现组间的主要结局无差异：45 (30%) (GDT 组) vs 39 (25%) (STD 组) (优势比 = 1.24；95% 置信区间, 0.75–2.05；P = 0.40)。GDT 组住院时间更长：中位数（四分位间距），7 天（4-12）vs 6 天（4-8.5）（P = 0.04）；没有发现其他差异。

结论

与压力引导的静脉输液治疗（STD 组）相比，流量引导的液体治疗接近最大每搏输出量（GDT 组）并未改善肠梗阻或胃肠道穿孔术后的预后，但可能延长住院时间。

临床试验注册

EudraCT编号2015-000563-14；丹麦科学伦理委员会和丹麦数据保护局 (REG-18-2015)。