Phase 3
N=136
Midodrine for the Treatment of Refractory Hypotension
Hypotension · Critical Illness
Bottom Line
View on ClinicalTrials.gov: NCT01531959 ↗Enrolled (actual)
136
Serious AEs
0.8%
Results posted
Sep 2019
Primary outcome: Primary: Time Until Discontinuation of IV Vasopressors — 23.5; 22.5 hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Midodrine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Until Discontinuation of IV Vasopressors |
23.5; 22.5 | — |
| SECONDARY ICU Length of Stay |
6.0; 6.0 | — |
| SECONDARY Hospital Length of Stay |
11.0; 14.0 | — |
| SECONDARY Rates of ICU Readmission |
1; 3 | — |
| SECONDARY Rates of Hypertension, Bradycardia, and Hemodynamically Significant Tacharrythmias |
12; 3 | — |
Summary
We hypothesize that midodrine treatment of refractory hypotension in patients otherwise ready for discharge from the ICU shortens duration of receiving IV vasopressors and SICU length of stay without increasing MGH length of stay or putting the patient at risk of being readmitted to an ICU.
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age
- Admitted to the SICU
- Requiring IV vasopressors at a rate of less than 100 mcg/min of phenylephrine, or 8 mcg/min of norepinephrine, or 60 mcg/min of metaraminol; and unable to wean for more than 24 hours while still maintaining desired blood pressure goal
Exclusion Criteria
- Inadequate tissue oxygenation
- Liver failure
- Renal failure
- Hypovolemic shock or hypotension due to adrenal insufficiency
- Pregnancy
- Severe organic heart disease
- Urinary retention
- Pheochromocytoma
- Thyrotoxicosis
- Midodrine as pre-admission medication
- Any known allergies to midodrine
- Enrollment in another clinical trial
Data sourced from ClinicalTrials.gov (NCT01531959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.