HypotensionPhase 3NCT01531959
Midodrine for the Treatment of Refractory Hypotension
A Phase 3 study testing Midodrine in people with Hypotension and Critical Illness, run by Massachusetts General Hospital at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension, Critical Illness
- What is being tested?
- Midodrine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Apr 2012to Jun 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inadequate tissue oxygenation
- Liver failure
- Renal failure
- Hypovolemic shock or hypotension due to adrenal insufficiency
- Pregnancy
- Severe organic heart disease
Show all 12Show fewer
- Urinary retention
- Pheochromocytoma
- Thyrotoxicosis
- Midodrine as pre-admission medication
- Any known allergies to midodrine
- Enrollment in another clinical trial
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Australia1 site
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 60009
About this study
Official title: Midodrine for the Treatment of Refractory Hypotension in Patients Otherwise Ready for Discharge From the ICU
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.
Read the detailed description
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
- Hypotension, Critical Illness
- Being tested
- Midodrine, Placebo
- Keywords
- Midodrine, Hypotension, Intensive care unit, IV vasopressors, ICU discharge
- Medical subject headings
- Hypotension, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidodrineDrug
Patients will be randomized to blinded to 20 mg of midodrine
PlaceboDrug
Patients will be randomized to blinded placebo control
| Study group | Role | What they receive |
|---|---|---|
| Midodrine | Active comparator | Not described Receives: Drug: Midodrine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Until Discontinuation of IV Vasopressors
Measured hours from initiation of midodrine until discontinuation of IV vasopressors
Measured: From initiation of the study drug until discontinuation of IV vasopressors, assessed up to 400 hours
Secondary outcomes (4)
ICU Length of Stay
Measured number of days from initiation of midodrine until discharge ready from the ICU
Measured: From initiation of midodrine until ICU discharge, assessed up to 45 days
Hospital Length of Stay
Measured number of days from initiation of midodrine until discharged from hospital
Measured: From initiation of midodrine until hospital discharge, assessed up to 90 days
Rates of ICU Readmission
Number of patients initiated on midodrine that are readmitted back to ICU after being discharged to floor
Measured: Up to 2 months after ICU discharge
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).
Measured: From initiation of the study drug until discontinuation of the study drug, an average of 59 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Charles Gairdner Hospital
- Responsible party
- Principal investigator, Matthias Eikermann, MD PhD, Beth Israel Deaconess Medical Center
- Investigators
- Matthias Eikermann, MD, PhD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531959
- Sponsor's protocol ID
- 2011P002049
- Other IDs
- 2015-098, 2018P000162
- Status last verified
- Oct 2020
- First submitted
- 9 Feb 2012
- Last updated
- 28 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 28327122
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midodrine for the Treatment of Refractory Hypotension in Patients Otherwise Ready for Discharge From the ICU
- ClinicalTrials.gov ID
- NCT01531959
- Acronym / sponsor ID
- 2011P002049
- Conditions
- Hypotension, Critical Illness
- Keywords
- Midodrine, Hypotension, Intensive care unit, IV vasopressors, ICU discharge
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Sir Charles Gairdner Hospital
- Study start
- Apr 2012
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 13 Feb 2012 (estimated)
- Results
- Posted 6 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midodrine | Active comparator | Drug: Midodrine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- Inadequate tissue oxygenation
- Liver failure
- Renal failure
- Hypovolemic shock or hypotension due to adrenal insufficiency
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidodrinePatients will be randomized to blinded to 20 mg of midodrine | Drug | Midodrine |
| PlaceboPatients will be randomized to blinded placebo control | Drug | Placebo |
Primary outcome
Time Until Discontinuation of IV Vasopressors
Time frame: From initiation of the study drug until discontinuation of IV vasopressors, assessed up to 400 hours
Measured hours from initiation of midodrine until discontinuation of IV vasopressors
4 secondary outcomes
ICU Length of Stay
Time frame: From initiation of midodrine until ICU discharge, assessed up to 45 days
Hospital Length of Stay
Time frame: From initiation of midodrine until hospital discharge, assessed up to 90 days
Rates of ICU Readmission
Time frame: Up to 2 months after ICU discharge
Rates of Hypertension, Bradycardia, and Hemodynamically Significant Tacharrythmias
Time frame: From initiation of the study drug until discontinuation of the study drug, an average of 59 hours.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28327122Anstey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Eikermann, MD, PhD principal investigator
Beth Israel Deaconess Medical Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Midodrine in people with Hypotension and Critical Illness, run by Massachusetts General Hospital at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Until Discontinuation of IV Vasopressors (time frame: From initiation of the study drug until discontinuation of IV vasopressors, assessed up to 400 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01531959, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.