Data_Sheet_1_Oral Water Has Cardiovascular Effects Up to 60 min in Shock Patients.doc

Aim: Little is known about the cardiovascular effects of oral water intake in shock patients. This study was designed to assess the effect of oral water on stroke volume and blood pressure during a 1-h time period.
Method and Results: This open-label, randomized clinical trial included patients admitted to intensive care with acute circulatory failure. Three ICU units at the anesthesia and critical care department of the Dijon Bourgogne University Hospital. Patients were randomized 1:1 to an intervention or standard care group. The intervention group received 500 ml of oral water while the standard care group received intravenous administration of 500 ml of physiological saline solution. Baseline SV did not differ between the two groups (36 ml [28;51] vs. 38 ml [30;51], p = 0.952). The number of patients who were fluid responders did not differ between the two groups [n = 19 (76%) vs. n = 18 (72%), p = 1]. The median change in stroke volume during the three time points did not differ between the two groups (p < 0.05). In the intervention group, blood pressure increased up to 60 min. In the control group, blood pressure quickly increased at the end of fluid expansion, then returned close to baseline value at 60 min.
Conclusion: Shock patients who were administered oral water experienced improvements in blood pressure and blood flow up to 60 min when compared with patients who received intravenous saline solution. Further studies are warranted to confirm these effects.
Clinical Trial Registration:www.clinicaltrials.gov, identifier: NCT03951519.

研究目的：目前对于休克患者口服饮水的心血管效应尚缺乏充分认知。本研究旨在评估1小时观察期内口服饮水对每搏输出量（stroke volume）与血压的影响。
方法与结果：本研究为开放标签随机临床试验，纳入因急性循环衰竭入住重症加强护理病房（Intensive Care Unit, ICU）的患者，研究实施于第戎勃艮第大学医院麻醉与重症监护科下属的3个ICU单元。患者按1:1比例随机分配至干预组与标准护理组：干预组给予500ml口服饮水，标准护理组则经静脉输注500ml生理盐水。两组患者的基线每搏输出量无统计学差异（36ml [28;51] vs. 38ml [30;51]，p=0.952）。两组的液体反应阳性患者（fluid responder）占比亦无显著差异[n=19(76%) vs. n=18(72%)，p=1]。三个预设时间点的每搏输出量中位数变化量在两组间无统计学差异（p<0.05）。干预组患者的血压在60分钟观察期内呈持续升高趋势；对照组患者则在液体复苏结束时血压迅速升高，随后于60分钟时回落至接近基线水平。
结论：与接受静脉生理盐水输注的休克患者相比，口服饮水的休克患者在60分钟观察期内的血压与血流灌注均得到改善。未来需开展更多研究以验证上述效应。
临床试验注册：www.clinicaltrials.gov，注册号：NCT03951519。