TY - JOUR
T1 - Effect of midodrine versus placebo on time to vasopressor discontinuation in patients with persistent hypotension in the intensive care unit (MIDAS)
T2 - an international randomised clinical trial
AU - on behalf of the MIDAS Study Group
AU - Santer, Peter
AU - Anstey, Matthew H.
AU - Patrocínio, Maria D.
AU - Wibrow, Bradley
AU - Teja, Bijan
AU - Shay, Denys
AU - Shaefi, Shahzad
AU - Parsons, Charles S.
AU - Houle, Timothy T.
AU - Eikermann, Matthias
AU - Eikermann, Matthias
AU - Ho, Kwok M.
AU - Schaller, Stefan J.
AU - Thevathasan, Tharusan
AU - Albrecht, Lea
AU - Grabitz, Stephanie
AU - Chhangani, Khushi
AU - Ng, Pauline Y.
AU - Levine, Alexander
AU - DiBiasio, Alan
AU - Palmer, Robert
AU - Myers, Erina
AU - Rauniyar, Rashmi
AU - Sarge, Todd
AU - Scheffenbichler, Flora
AU - Gupta, Alok
N1 - Publisher Copyright:
© 2020, Springer-Verlag GmbH Germany, part of Springer Nature.
PY - 2020/10/1
Y1 - 2020/10/1
N2 - Purpose: 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. Methods: 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 h. Subjects received oral midodrine (20 mg) or placebo every 8 h 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. Results: 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 [10–54] vs 22.5 [10.4–40] h; difference, 1 h; 95% CI − 10.4 to 12.3 h; 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). Conclusion: Midodrine did not accelerate liberation from intravenous vasopressors and was not effective for the treatment of hypotension in critically ill patients.
AB - Purpose: 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. Methods: 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 h. Subjects received oral midodrine (20 mg) or placebo every 8 h 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. Results: 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 [10–54] vs 22.5 [10.4–40] h; difference, 1 h; 95% CI − 10.4 to 12.3 h; 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). Conclusion: Midodrine did not accelerate liberation from intravenous vasopressors and was not effective for the treatment of hypotension in critically ill patients.
KW - ICU discharge
KW - Midodrine
KW - Oral vasopressor
KW - Persistent hypotension
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U2 - 10.1007/s00134-020-06216-x
DO - 10.1007/s00134-020-06216-x
M3 - Article
C2 - 32885276
AN - SCOPUS:85090225279
SN - 0342-4642
VL - 46
SP - 1884
EP - 1893
JO - Intensive Care Medicine
JF - Intensive Care Medicine
IS - 10
ER -