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一项多中心、开放标签、随机对照试验,比较了心脏手术后患者采用保守液体管理策略与常规治疗的效果:体外循环后液体研究。

A Multicenter, Open-Label, Randomized Controlled Trial of a Conservative Fluid Management Strategy Compared With Usual Care in Participants After Cardiac Surgery: The Fluids After Bypass Study.

机构信息

Cardiothoracic and Vascular ICU, Auckland City Hospital, Auckland, New Zealand.

School of Nursing, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.

出版信息

Crit Care Med. 2021 Mar 1;49(3):449-461. doi: 10.1097/CCM.0000000000004883.

Abstract

OBJECTIVES

There is little evidence to guide fluid administration to patients admitted to the ICU following cardiac surgery. This study aimed to determine if a protocolized strategy known to reduce fluid administration when compared with usual care reduced ICU length of stay following cardiac surgery.

DESIGN

Prospective, multicenter, parallel-group, randomized clinical trial.

SETTING

Five cardiac surgical centers in New Zealand conducted from November 2016 to December 2018 with final follow-up completed in July 2019.

PATIENTS

Seven-hundred fifteen patients undergoing cardiac surgery; 358 intervention and 357 usual care.

INTERVENTIONS

Randomization to protocol-guided strategy utilizing stroke volume variation to guide administration of bolus fluid or usual care fluid administration until desedation or up to 24 hours. Primary outcome was length of stay in ICU. Organ dysfunction, mortality, process of care measures, patient-reported quality of life, and disability-free survival were collected up to day 180.

MEASUREMENTS AND MAIN RESULTS

Overall 666 of 715 (93.1%) received at least one fluid bolus. Patients in the intervention group received less bolus fluid (median [interquartile range], 1,000 mL [250-2,000 mL] vs 1,500 mL [500-2,500 mL]; p < 0.0001) and had a lower overall fluid balance (median [interquartile range], 319 mL [-284 to 1,274 mL] vs 673 mL [38-1,641 mL]; p < 0.0001) in the intervention period. There was no difference in ICU length of stay between the two groups (27.9 hr [21.8-53.5 hr] vs 25.6 hr [21.9-64.6 hr]; p = 0.95). There were no differences seen in development of organ dysfunction, quality of life, or disability-free survival at any time points. Hospital mortality was higher in the intervention group (4% vs 1.4%; p = 0.04).

CONCLUSIONS

A protocol-guided strategy utilizing stroke volume variation to guide administration of bolus fluid when compared with usual care until desedation or up to 24 hours reduced the amount of fluid administered but did not reduce the length of stay in ICU.

摘要

目的

心脏手术后入住 ICU 的患者的输液管理证据有限。本研究旨在确定与常规护理相比,一种已知可减少输液量的方案策略是否会缩短心脏手术后患者的 ICU 住院时间。

设计

前瞻性、多中心、平行组、随机临床试验。

地点

2016 年 11 月至 2018 年 12 月在新西兰的 5 个心脏外科中心进行,最终随访于 2019 年 7 月完成。

患者

715 例接受心脏手术的患者;358 例干预组,357 例常规护理组。

干预措施

随机分配至方案指导策略,利用每搏量变异度指导输液或常规护理输液,直至镇静或最长 24 小时。主要结局为 ICU 住院时间。收集器官功能障碍、死亡率、护理过程措施、患者报告的生活质量以及无残疾生存至 180 天。

测量和主要结果

总体而言,715 例患者中有 666 例(93.1%)至少接受了一次液体冲击。干预组患者接受的液体冲击量较少(中位数[四分位距],1000ml[250-2000ml] vs 1500ml[500-2500ml];p<0.0001),在干预期间的总体液体平衡也较低(中位数[四分位距],319ml[-284 至 1274ml] vs 673ml[38-1641ml];p<0.0001)。两组 ICU 住院时间无差异(27.9 小时[21.8-53.5 小时] vs 25.6 小时[21.9-64.6 小时];p=0.95)。在任何时间点,器官功能障碍、生活质量或无残疾生存的发展均无差异。干预组的医院死亡率较高(4% vs 1.4%;p=0.04)。

结论

与常规护理相比,使用每搏量变异度指导输液的方案指导策略在镇静或最长 24 小时内可减少输液量,但并未缩短 ICU 住院时间。

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