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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01531959




Registration number
NCT01531959
Ethics application status
Date submitted
9/02/2012
Date registered
13/02/2012
Date last updated
28/10/2020

Titles & IDs
Public title
Midodrine for the Treatment of Refractory Hypotension
Scientific title
Midodrine for the Treatment of Refractory Hypotension in Patients Otherwise Ready for Discharge From the ICU
Secondary ID [1] 0 0
2015-098
Secondary ID [2] 0 0
2011P002049
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypotension 0 0
Critical Illness 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Midodrine
Treatment: Drugs - Placebo

Active Comparator: Midodrine -

Placebo Comparator: Placebo -


Treatment: Drugs: Midodrine
Patients will be randomized to blinded to 20 mg of midodrine

Treatment: Drugs: Placebo
Patients will be randomized to blinded placebo control

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time Until Discontinuation of IV Vasopressors - Measured hours from initiation of midodrine until discontinuation of IV vasopressors
Timepoint [1] 0 0
From initiation of the study drug until discontinuation of IV vasopressors, assessed up to 400 hours
Secondary outcome [1] 0 0
ICU Length of Stay - Measured number of days from initiation of midodrine until discharge ready from the ICU
Timepoint [1] 0 0
From initiation of midodrine until ICU discharge, assessed up to 45 days
Secondary outcome [2] 0 0
Hospital Length of Stay - Measured number of days from initiation of midodrine until discharged from hospital
Timepoint [2] 0 0
From initiation of midodrine until hospital discharge, assessed up to 90 days
Secondary outcome [3] 0 0
Rates of ICU Readmission - Number of patients initiated on midodrine that are readmitted back to ICU after being discharged to floor
Timepoint [3] 0 0
Up to 2 months after ICU discharge
Secondary outcome [4] 0 0
Rates of Hypertension, Bradycardia, and Hemodynamically Significant Tacharrythmias - Measured rates of hypertension (increase in systolic blood pressure to values higher than those set by the primary team or greater than 160 mmg), bradycardia (decrease in heart rate to values lower than those set by the primary team or less than 40 BPM), hemodynamically significant tachyarrythmias (greater than 20 mmhg decrease in systolic blood pressure).
Timepoint [4] 0 0
From initiation of the study drug until discontinuation of the study drug, an average of 59 hours.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
60009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts

Funding & Sponsors
Primary sponsor type
Other
Name
Massachusetts General Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Sir Charles Gairdner Hospital
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT01531959
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Matthias Eikermann, MD, PhD
Address 0 0
Beth Israel Deaconess Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications