Rahul Costa-Pinto1, Zhen-Ti Yong2, Fumitaka Yanase3, Chelsea Young4, Alastair Brown2, Andrew Udy5, Paul J Young6, Glenn Eastwood2, Rinaldo Bellomo7. 1. Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia; Department of Critical Care, Department of Medicine, the University of Melbourne, Parkville, Victoria, Australia. Electronic address: rahul.costa-pinto@austin.org.au. 2. Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia. 3. Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia; Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia. 4. Department of Intensive Care, Wellington Regional Hospital, 49 Riddiford Street, Newtown, Wellington, New Zealand. 5. Department of Intensive Care, The Alfred Hospital, 55 Commercial Road, Melbourne, Victoria, Australia; Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia. 6. Department of Intensive Care, Wellington Regional Hospital, 49 Riddiford Street, Newtown, Wellington, New Zealand; Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; Medical Research Institute of New Zealand, Private Bag, 7902, Wellington, New Zealand; Department of Critical Care, Department of Medicine, the University of Melbourne, Parkville, Victoria, Australia. 7. Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia; Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; Department of Intensive Care, Royal Melbourne Hospital, Melbourne, Victoria, Australia; Department of Critical Care, Department of Medicine, the University of Melbourne, Parkville, Victoria, Australia; Data Analytics Research and Evaluation Centre, The University of Melbourne and Austin Hospital, Melbourne, Australia.
Abstract
PURPOSE: To assess the feasibility and physiological efficacy of adjunctive midodrine in patients with vasopressor-dependent hypotension. MATERIALS AND METHODS: This was a pilot, open label, randomised controlled trial. Patients were enrolled from two tertiary intensive care units on low dose intravenous vasopressor therapy for more than 24 h. We randomly assigned patients to receive either adjunctive midodrine (10 mg every 8 h) or usual care. The primary efficacy outcome was time to cessation of intravenous vasopressor therapy. Secondary outcomes included protocol compliance, ICU and hospital length of stay. RESULTS: We screened 381 patients over 22-months and enrolled 62 (32 in midodrine group, 30 in usual care group). Median time to cessation of vasopressor infusion was 16.5 h for midodrine vs 19 h for usual care (p = 0.22). Time in ICU (50 [25.50, 74.00] hours for midodrine v 59 [38.50, 93.25] hours for usual care, p = 0.14) and hospital length of stay (9 days vs. 7.5 days, p = 0.92) were similar. Protocol compliance was 96.9%. One patient ceased midodrine early due to symptomatic bradycardia. CONCLUSIONS: Adjunctive midodrine therapy was feasible with acceptable compliance, duration of therapy, and safety profile. However, at the chosen dose, there was no evidence of physiological or clinical efficacy.
PURPOSE: To assess the feasibility and physiological efficacy of adjunctive midodrine in patients with vasopressor-dependent hypotension. MATERIALS AND METHODS: This was a pilot, open label, randomised controlled trial. Patients were enrolled from two tertiary intensive care units on low dose intravenous vasopressor therapy for more than 24 h. We randomly assigned patients to receive either adjunctive midodrine (10 mg every 8 h) or usual care. The primary efficacy outcome was time to cessation of intravenous vasopressor therapy. Secondary outcomes included protocol compliance, ICU and hospital length of stay. RESULTS: We screened 381 patients over 22-months and enrolled 62 (32 in midodrine group, 30 in usual care group). Median time to cessation of vasopressor infusion was 16.5 h for midodrine vs 19 h for usual care (p = 0.22). Time in ICU (50 [25.50, 74.00] hours for midodrine v 59 [38.50, 93.25] hours for usual care, p = 0.14) and hospital length of stay (9 days vs. 7.5 days, p = 0.92) were similar. Protocol compliance was 96.9%. One patient ceased midodrine early due to symptomatic bradycardia. CONCLUSIONS: Adjunctive midodrine therapy was feasible with acceptable compliance, duration of therapy, and safety profile. However, at the chosen dose, there was no evidence of physiological or clinical efficacy.