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Midodrine for the Treatment of Refractory Hypotension

NCT ID: NCT01531959

Last Updated: 2020-10-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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Persistent hypotension in critically ill patients remains a major barrier to discharging patients from the intensive care unit (ICU). In our hospital, in patients with adequate tissue perfusion, midodrine has been observed to treat hypotension in order to wean continuous intravenous (IV) vasopressors and therefore promote ICU discharge. There are several possible etiologies of hypotension in the ICU. The most frequently seen causes include septic shock, hypovolemia, adrenal insufficiency, and idiosyncratic reactions from medications. For patients whose reversible causes of hypotension have been addressed but still require vasopressors, midodrine may prove to be a useful adjunctive medication to successfully increase blood pressure. No previous studies have examined the use of midodrine for the treatment of hypotension in an ICU setting. Therefore, we are investigating a new indication for midodrine as the treatment of hypotension in critically ill patients.

Conditions

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Hypotension Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Midodrine

Group Type ACTIVE_COMPARATOR

Midodrine

Intervention Type DRUG

Patients will be randomized to blinded to 20 mg of midodrine

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients will be randomized to blinded placebo control

Interventions

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Midodrine

Patients will be randomized to blinded to 20 mg of midodrine

Intervention Type DRUG

Placebo

Patients will be randomized to blinded placebo control

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sir Charles Gairdner Hospital

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Matthias Eikermann, MD PhD

Vice Chair of Faculty Affairs of the Department of Anesthesia Critical Care and Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthias Eikermann, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Site Status

Countries

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United States Australia

References

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Anstey MH, Wibrow B, Thevathasan T, Roberts B, Chhangani K, Ng PY, Levine A, DiBiasio A, Sarge T, Eikermann M. Midodrine as adjunctive support for treatment of refractory hypotension in the intensive care unit: a multicenter, randomized, placebo controlled trial (the MIDAS trial). BMC Anesthesiol. 2017 Mar 21;17(1):47. doi: 10.1186/s12871-017-0339-x.

Reference Type DERIVED
PMID: 28327122 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2015-098

Identifier Type: OTHER

Identifier Source: secondary_id

2018P000162

Identifier Type: OTHER

Identifier Source: secondary_id

2011P002049

Identifier Type: -

Identifier Source: org_study_id