Effect of midodrine versus placebo on time to vasopressor discontinuation in patients with persistent hypotension in the intensive care unit (MIDAS): an international randomised clinical trial.
Effect of midodrine versus placebo on time to vasopressor discontinuation in patients with persistent hypotension in the intensive care unit (MIDAS): an international randomised clinical trial.
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DOI：
10.1007/s00134-020-06216-x
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发表时间：
2020-10
影响因子：
38.9
通讯作者：
MIDAS Study Group
中科院分区：
文献类型：
--
作者：
Santer P;Anstey MH;Patrocínio MD;Wibrow B;Teja B;Shay D;Shaefi S;Parsons CS;Houle TT;Eikermann M;MIDAS Study Group
ICU出院通常会因为需要静脉注射血管升压药以维持正常血压而延迟。我们假设，口服α1-肾上腺素能激动剂米多君作为标准治疗的辅助治疗可以缩短静脉注射加压药的持续时间。在这项多中心、随机、对照的试验中，包括美国和澳大利亚的三家三级转诊医院，我们招募了需要单一药物静脉血管加压剂治疗≥24小时的低血压成年患者。受试者在标准护理的基础上每隔8小时口服米多君(20毫克)或安慰剂，直到停止静脉注射血管增压药、ICU出院或发生不良事件。主要结果是血管加压剂停用的时间。次要结果包括ICU出院准备时间、ICU和住院时间以及ICU再住院率。在2012年10月至2019年6月期间，136名参与者被随机分配，其中132人接受了分配的干预并被纳入分析(改进的意向治疗方法)。米多君组和安慰剂组的血管加压药停药时间无差异(中位数分别为23.5[10.0-54.0]小时和22.5[10.4-40.0]小时；差异为1.0小时；95%可信区间，−为10.4-12.3小时；p=0.62)。次要终点的差异没有观察到。使用米多君后，心动过缓的发生率更高(5[7.6%]vs 0[0%]，p=0.02)。米多君不能加速血管升压剂的释放，对危重病患者的低血压治疗无效。NCT01531959,2012年2月13日注册
ICU discharge is often delayed by a requirement for intravenous vasopressor medications to maintain normotension. We hypothesised that the administration of midodrine, an oral α1-adrenergic agonist, as adjunct to standard treatment shortens the duration of intravenous vasopressor requirement. In this multicentre, randomised, controlled trial including three tertiary referral hospitals in the US and Australia, we enrolled adult patients with hypotension requiring a single-agent intravenous vasopressor for ≥24 hours. Subjects received oral midodrine (20 mg) or placebo every 8 hours in addition to standard care until cessation of intravenous vasopressors, ICU discharge, or occurrence of adverse events. The primary outcome was time to vasopressor discontinuation. Secondary outcomes included time to ICU discharge readiness, ICU and hospital lengths of stay, and ICU readmission rates. Between October 2012 and June 2019, 136 participants were randomised, of whom 132 received the allocated intervention and were included in the analysis (modified intention-to-treat approach). Time to vasopressor discontinuation was not different between midodrine and placebo groups (median [IQR], 23.5 [10.0–54.0] vs 22.5 [10.4–40.0] hours; difference, 1.0 hour; 95% CI, −10.4 to 12.3 hours; p=0.62). No differences in secondary endpoints were observed. Bradycardia occurred more often after midodrine administration (5 [7.6%] vs 0 [0%], p=0.02). Midodrine did not accelerate liberation from intravenous vasopressors and was not effective for the treatment of hypotension in critically ill patients. NCT01531959, registered on February 13, 2012
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DOI：
10.1007/s10286-016-0363-9
发表时间：
2016-08
期刊：
Clinical autonomic research : official journal of the Clinical Autonomic Research Society
影响因子：
--
作者：
Smith W;Wan H;Much D;Robinson AG;Martin P
通讯作者：
Martin P
影响因子：
2.2
作者：
Anstey, Matthew H.;Wibrow, Bradley;Eikermann, Matthias
通讯作者：
Eikermann, Matthias
DOI：
10.1177/107424840501000109
发表时间：
2005-03-01
影响因子：
2.6
作者：
Sharma, S;Bhambi, B
通讯作者：
Bhambi, B
DOI：
10.1111/j.1365-2125.1975.tb00568.x
发表时间：
1975-01-01
影响因子：
3.4
作者：
NIMMO, WS;HEADING, RC;PRESCOTT, LF
通讯作者：
PRESCOTT, LF
影响因子：
2.2
作者：
Ladopoulos T;Giannaki M;Alexopoulou C;Proklou A;Pediaditis E;Kondili E
通讯作者：
Kondili E