HypotensionPhase 4NCT02771158
Midodrine During Recovery From Septic Shock
A Phase 4 study testing Midodrine in people with Hypotension and Shock, Septic, run by Northwell Health.
Trial summary
The purpose of this study is to determine whether midodrine administration decreases duration of intravenous vasopressors and intensive care unit length of stay for patients in septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension, Shock, Septic, Sepsis
- What is being tested?
- Midodrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2017to 1 Nov 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- admitted to intensive care unit
- diagnosis of septic shock on intravenous vasopressors
- stable/decreasing doses of intravenous vasopressors
- stable/improving organ function
Who cannot join
- allergy to midodrine
- multiple intravenous vasopressors
- increasing intravenous vasopressor requirements
- worsening organ dysfunction
- severe bradycardia
About this study
Official title: A Randomized Controlled Trial of Midodrine During Recovery Phase From Septic Shock
The purpose of this study is to determine whether midodrine administration decreases duration of intravenous vasopressors and intensive care unit length of stay for patients in septic shock.
- Conditions
- Hypotension, Shock, Septic, Sepsis
- Being tested
- Midodrine, placebo
- Keywords
- critical care, shock, septic, sepsis, hypotension, midodrine
- Medical subject headings
- Hypotension, Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidodrineDrug
Also called proamatine
midodrine is metabolized to an active metabolite, desglymidodrine, which is an alpha adrenergic antagonist that causes vasoconstriction of both venous and arterial vasculature, thereby increasing blood pressure
placeboDrug
placebo will be administered to double blind the study
| Study group | Role | What they receive |
|---|---|---|
| midodrine | Experimental | randomization to midodrine 20 mg every 8 hours to be increased to a maximum of 40 mg every 8 hours until intravenous vasopressor discontinuation Receives: Drug: Midodrine |
| placebo | Placebo comparator | randomization to placebo control Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of intravenous vasopressors
Measured: from enrollment until discontinuation of intravenous vasopressors, expected to be 3-5 days
Secondary outcomes (5)
intensive care unit length of stay
Measured: from enrollment until eligible for discharge from intensive care unit, expected to be 4-7 days
re-institution of intravenous vasopressor
Measured: from enrollment until hospital discharge, expected to be up to 30 days
hospital length of stay
Measured: from enrollment until hospital discharge, expected to be up to 30 days
mortality
Measured: from enrollment until hospital discharge, expected to be up to 30 days
midodrine side effects requiring discontinuation
including supine hypertension and bradycardia
Measured: from enrollment until hospital discharge, expected to be up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startAug 2017 (estimated)
- Primary completion1 Nov 2017
- Study completion1 Nov 2017
Why it stopped: Study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771158
- Sponsor's protocol ID
- temp-1187
- Status last verified
- Nov 2017
- First submitted
- 28 Mar 2016
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Whitson MR, Mo E, Nabi T, Healy L, Koenig S, Narasimhan M, Mayo PH. Feasibility, Utility, and Safety of Midodrine During Recovery Phase From Septic Shock. Chest. 2016 Jun;149(6):1380-3. doi: 10.1016/j.chest.2016.02.657. Epub 2016 Mar 4.
PubMed 26953217
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Midodrine During Recovery Phase From Septic Shock
- ClinicalTrials.gov ID
- NCT02771158
- Acronym / sponsor ID
- temp-1187
- Conditions
- Hypotension, Shock, Septic, Sepsis
- Keywords
- critical care, shock, septic, sepsis, hypotension, midodrine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Aug 2017 (estimated)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether midodrine administration decreases duration of intravenous vasopressors and intensive care unit length of stay for patients in septic shock.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| midodrine | Experimental | Drug: Midodrinerandomization to midodrine 20 mg every 8 hours to be increased to a maximum of 40 mg every 8 hours until intravenous vasopressor discontinuation |
| placebo | Placebo comparator | Drug: placeborandomization to placebo control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- admitted to intensive care unit
- diagnosis of septic shock on intravenous vasopressors
- stable/decreasing doses of intravenous vasopressors
- stable/improving organ function
Key exclusion criteria (5 listed)
- allergy to midodrine
- multiple intravenous vasopressors
- increasing intravenous vasopressor requirements
- worsening organ dysfunction
- severe bradycardia
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 |
|---|---|---|
| MidodrineAlso: proamatinemidodrine is metabolized to an active metabolite, desglymidodrine, which is an alpha adrenergic antagonist that causes vasoconstriction of both venous and arterial vasculature, thereby increasing blood pressure | Drug | midodrine |
| placeboplacebo will be administered to double blind the study | Drug | placebo |
Primary outcome
duration of intravenous vasopressors
Time frame: from enrollment until discontinuation of intravenous vasopressors, expected to be 3-5 days
5 secondary outcomes
intensive care unit length of stay
Time frame: from enrollment until eligible for discharge from intensive care unit, expected to be 4-7 days
re-institution of intravenous vasopressor
Time frame: from enrollment until hospital discharge, expected to be up to 30 days
hospital length of stay
Time frame: from enrollment until hospital discharge, expected to be up to 30 days
mortality
Time frame: from enrollment until hospital discharge, expected to be up to 30 days
midodrine side effects requiring discontinuation
Time frame: from enrollment until hospital discharge, expected to be up to 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Background: PubMed 26953217Whitson MR, Mo E, Nabi T, Healy L, Koenig S, Narasimhan M, Mayo PH. Feasibility, Utility, and Safety of Midodrine During Recovery Phase From Septic Shock. Chest. 2016 Jun;149(6):1380-3. doi: 10.1016/j.chest.2016.02.657. Epub 2016 Mar 4.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Midodrine in people with Hypotension and Shock, Septic, run by Northwell Health.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
duration of intravenous vasopressors (time frame: from enrollment until discontinuation of intravenous vasopressors, expected to be 3-5 days). 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 NCT02771158, 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 6 Nov 2017.