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利尿剂降低有创机械通气患者的液体平衡:随机对照单盲、IRIHS 研究。

Diuretics decrease fluid balance in patients on invasive mechanical ventilation: the randomized-controlled single blind, IRIHS study.

机构信息

CHU Nantes, Pôle Anesthésie-Réanimation, Service d'Anesthésie Réanimation Chirurgicale, Hôpital Guillaume et René Laennec, Université de Nantes, 44800, Saint-Herblain, France.

Médecine Intensive et Réanimation, Hôtel Dieu, University Hospital of Nantes, 1 place Alexis Ricordeau, 44093, Nantes, France.

出版信息

Crit Care. 2021 Mar 10;25(1):98. doi: 10.1186/s13054-021-03509-5.

DOI:10.1186/s13054-021-03509-5
PMID:33691730
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7943707/
Abstract

BACKGROUND

Fluid overload has been associated with increased morbidity and mortality in critically ill patients. The goal of this study was to assess the efficacy and safety of a diuretic strategy to overcome positive fluid balance in patients on invasive mechanical ventilation.

METHODS

Design: Multicenter, single-blind, randomized-controlled study. Patients were randomized into a diuretic (furosemide) or a control group. Patients were eligible in case of fluid overload defined as in-ICU weight increase ≥ 3%, invasive mechanical ventilation (FiO ≤ 60% and PEEP ≤ 10 cm HO on inclusion) and hemodynamic stabilization. The primary outcome was fluid balance, defined as weight variation from reference weight to successful extubation. The main secondary outcome was the safety of diuretic.

RESULTS

171 patients were randomized. After 5 exclusions, 166 patients were included in the analysis: 77 in the diuretic and 89 in the control group. Fluid balance was 1.4 [- 2.5 to 4.5] kg in the diuretic and 6.4 [0.5-11.2] kg in the control group (p < 0.001). In the multiple imputation analysis, fluid balance was significantly decreased in the diuretic group (mean difference = - 4.8 95% CI [- 7.3 to - 2.5], p < 0.001). Eleven (14%) patients died in the diuretic group and 16 (18%) patients in the control group (p = 0.5). There was a worsening of Acute Kidney Injury in 67 (75.3%) patients of the control group versus 46 (59.7%) patients in the diuretic group (p = 0.03).

CONCLUSIONS

In this multicenter randomized-controlled study, protocolized diuretic therapy reduced fluid accumulation in patients receiving mechanical ventilation and was well tolerated with a favorable safety profile. Trial registration NCT02345681, Registered January 26 2015, Prospectively registered, https://clinicaltrials.gov/ct2/show/NCT02345681?term=02345681&draw=2&rank=1 .

摘要

背景

液体超负荷与重症患者的发病率和死亡率增加有关。本研究的目的是评估一种利尿剂策略在接受有创机械通气的患者中克服正性液体平衡的疗效和安全性。

方法

设计:多中心、单盲、随机对照研究。患者被随机分为利尿剂(呋塞米)或对照组。患者符合以下标准即可入选:定义为 ICU 内体重增加≥3%、有创机械通气(纳入时 FiO2≤60%和 PEEP≤10cmHO)和血流动力学稳定。主要结局是液体平衡,定义为参考体重与成功拔管时的体重变化。主要次要结局是利尿剂的安全性。

结果

171 名患者被随机分组。排除 5 例后,166 名患者纳入分析:利尿剂组 77 例,对照组 89 例。利尿剂组的液体平衡为 1.4[-2.5 至 4.5]kg,对照组为 6.4[0.5-11.2]kg(p<0.001)。在多重插补分析中,利尿剂组的液体平衡显著减少(平均差异=-4.8,95%CI[-7.3 至-2.5],p<0.001)。利尿剂组 11(14%)例患者死亡,对照组 16(18%)例患者死亡(p=0.5)。对照组 67(75.3%)例患者急性肾损伤恶化,而利尿剂组 46(59.7%)例患者恶化(p=0.03)。

结论

在这项多中心随机对照研究中,方案化的利尿剂治疗减少了接受机械通气患者的液体蓄积,且耐受性良好,安全性良好。试验注册 NCT02345681,2015 年 1 月 26 日注册,前瞻性注册,https://clinicaltrials.gov/ct2/show/NCT02345681?term=02345681&draw=2&rank=1。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2ae/7945355/d94cfd8a9caa/13054_2021_3509_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2ae/7945355/d94cfd8a9caa/13054_2021_3509_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2ae/7945355/d94cfd8a9caa/13054_2021_3509_Fig1_HTML.jpg

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