NCT01531959

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2012

Longer than P75 for phase_3

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
3 months until next milestone

Results Posted

Study results publicly available

September 6, 2019

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

7.2 years

First QC Date

February 9, 2012

Results QC Date

August 25, 2020

Last Update Submit

October 5, 2020

Conditions

HypotensionCritical Illness

Keywords

MidodrineHypotensionIntensive care unitIV vasopressorsICU discharge

Outcome Measures

Primary Outcomes (1)

  • Time Until Discontinuation of IV Vasopressors

    Measured hours from initiation of midodrine until discontinuation of IV vasopressors

    From initiation of the study drug until discontinuation of IV vasopressors, assessed up to 400 hours

Secondary Outcomes (4)

  • ICU Length of Stay

    From initiation of midodrine until ICU discharge, assessed up to 45 days

  • Hospital Length of Stay

    From initiation of midodrine until hospital discharge, assessed up to 90 days

  • Rates of ICU Readmission

    Up to 2 months after ICU discharge

  • Rates of Hypertension, Bradycardia, and Hemodynamically Significant Tacharrythmias

    From initiation of the study drug until discontinuation of the study drug, an average of 59 hours.

Study Arms (2)

Midodrine

ACTIVE COMPARATOR
Drug: Midodrine

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MidodrineDRUG

Patients will be randomized to blinded to 20 mg of midodrine

Midodrine
PlaceboDRUG

Patients will be randomized to blinded placebo control

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 60009, Australia

Location

Related Publications (1)

  • 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.

    PMID: 28327122DERIVED

MeSH Terms

Conditions

HypotensionCritical Illness

Interventions

Midodrine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Results Point of Contact

Title
Matthias Eikermann
Organization
Beth Israel Deaconess Medical Center
meikerma@bidmc.harvard.edu
6176327034

Study Officials

  • Matthias Eikermann, MD, PhD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Chair of Faculty Affairs of the Department of Anesthesia Critical Care and Pain Medicine

Study Record Dates

First Submitted

February 9, 2012

First Posted

February 13, 2012

Study Start

April 1, 2012

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

October 28, 2020

Results First Posted

September 6, 2019

Record last verified: 2020-10

Locations

US(2)AU(1)