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Midodrine During Recovery From Septic Shock

A Randomized Controlled Trial of Midodrine During Recovery Phase From Septic Shock

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02771158
Enrollment
0
Registered
2016-05-12
Start date
2017-08-31
Completion date
2017-11-01
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension, Sepsis, Shock, Septic

Keywords

critical care, shock, septic, sepsis, hypotension, midodrine

Brief summary

The purpose of this study is to determine whether midodrine administration decreases duration of intravenous vasopressors and intensive care unit length of stay for patients in septic shock.

Interventions

DRUGMidodrine

midodrine is metabolized to an active metabolite, desglymidodrine, which is an alpha adrenergic antagonist that causes vasoconstriction of both venous and arterial vasculature, thereby increasing blood pressure

DRUGplacebo

placebo will be administered to double blind the study

Sponsors

Northwell Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* admitted to intensive care unit * diagnosis of septic shock on intravenous vasopressors * stable/decreasing doses of intravenous vasopressors * stable/improving organ function

Exclusion criteria

* allergy to midodrine * multiple intravenous vasopressors * increasing intravenous vasopressor requirements * worsening organ dysfunction * severe bradycardia

Design outcomes

Primary

MeasureTime frame
duration of intravenous vasopressorsfrom enrollment until discontinuation of intravenous vasopressors, expected to be 3-5 days

Secondary

MeasureTime frameDescription
intensive care unit length of stayfrom enrollment until eligible for discharge from intensive care unit, expected to be 4-7 days
re-institution of intravenous vasopressorfrom enrollment until hospital discharge, expected to be up to 30 days
hospital length of stayfrom enrollment until hospital discharge, expected to be up to 30 days
mortalityfrom enrollment until hospital discharge, expected to be up to 30 days
midodrine side effects requiring discontinuationfrom enrollment until hospital discharge, expected to be up to 30 daysincluding supine hypertension and bradycardia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026