Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
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
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
Timepoint [3] 0 0
Up to 2 months after ICU discharge
Secondary outcome [4] 0 0
Rates of Hypertension, Bradycardia, and Hemodynamically Significant Tacharrythmias
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
Sex
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
1/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2019
Sample size
Target
Accrual to date
Final
139
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol Study Protocol and Statistical Analysis Plan
Statistical analysis plan Study Protocol and Statistical Analysis Plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01531959