Use of Midodrine in Post-cardiopulmonary Bypass Vasoplegic SyndromePhase 4NCT04668859
Midodrine as Novel Treatment of Post-Cardiopulmonary Bypass Vasoplegic Syndrome
A Phase 4 study testing Midodrine and Methylcellulose in people with Use of Midodrine in Post-cardiopulmonary Bypass Vasoplegic Syndrome, run by Medstar Health Research Institute.
Trial summary
Vasoplegic syndrome (VS) is a common and serious complication of cardiopulmonary bypass (CPB) procedures associated with a significant increase in morbidity and mortality. VS is defined as significant hypotension, high or normal cardiac outputs, low systemic vascular resistance, low cardiac filling pressures, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Use of Midodrine in Post-cardiopulmonary Bypass Vasoplegic Syndrome
- What is being tested?
- Midodrine and Methylcellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 29 Jul 2016to 8 Aug 2018
- 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
- post-cardiopulmonary bypass surgery
- vasoplegic syndrome criteria
- MAP < 65mmHg
- Cardiac index>/=2.4 L/min/m^2, as determined by Swan-
- systemic vascular resistance index </=1400 dynes s/cm^5/m^2
- adequate fluid resuscitation as determined by treating critical care team
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- vasopressor requirement
- norepinephrine 0.05-0.5 mcg/kg/min WITH/WITHOUT
- vasopressin any dose
Who cannot join
- allergy to midodrine
- pregnancy
- midodrine or cardiac glycoside as preadmission medication
- history of orthostatic hypotension, thyrotoxicosis, or pheochromocytoma
- severe organic heart disease (endocarditis, untreated congenital or rheumatic heart disease)
- liver failure/cirrhosis
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- chronic kidney disease (GFR <30mL/hr)
- ventricular assist device implantation procedure, intra-aortic balloon pump placement, or heart transplantion
- unresolved post-operative acute kidney injury (rise in serum creatinine by >/= 0.5mg/dl from baseline
- inadequate tissue oxygenation (lactate > 2 mmol/L)
- inability to take oral medications
About this study
Vasoplegic syndrome (VS) is a common and serious complication of cardiopulmonary bypass (CPB) procedures associated with a significant increase in morbidity and mortality. VS is defined as significant hypotension, high or normal cardiac outputs, low systemic vascular resistance, low cardiac filling pressures, and vasopressor requirement despite adequate fluid resuscitation following CPB. Extensive research has been performed regarding the pathophysiologic response to CPB and risk factors associated with VS. No safe and effective preventive strategy has gained widespread use. Supportive care with intravenous (IV) vasopressors has thus been adopted as standard of care. The use of these medications, while effective in the majority of patients, generally necessitates close monitoring in an intensive care unit (ICU) setting. These patients are subject to prolonged ICU and hospital stays, as well as the potential complications of prolonged use of central venous lines (CVL) required to give these medications. Recent studies suggest midodrine, a generic oral vasopressor, may accelerate the decline in IV vasopressor requirements in select ICU patients. At our institution, the addition of midodrine to IV vasopressors for the treatment of VS has been observed to be effective in reducing IV vasopressor duration. No literature exists describing the use of midodrine in this patient population. The goal of this study is to investigate the novel use of midodrine in CPB surgery complicated by VS. Ultimately, we hope to produce literature supporting its use that may be applied on a global scale to improve patient care
- Being tested
- Midodrine, Methylcellulose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidodrineDrug
Oral vasoactive that is metabolized by the liver an peripheral tissues into desglymidodrine, an active metabolite. It produces arteriolar and venous constriction with a subsequent elevation in blood pressure.
MethylcelluloseDrug
Placebo will consist of inert methylcellulose
| Study group | Role | What they receive |
|---|---|---|
| Midodrine Arm | Active comparator | Patients will receive the drug Midodrine Receives: Drug: Midodrine |
| Placebo Arm | Placebo comparator | Patients will receive placebo. Receives: Drug: Methylcellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from procedure end until discontinuation of IV vasopressors
Measured: 12 months
Secondary outcomes (6)
Rate of decline in IV vasopressor dose
Measured: 12 months
Time until CVL removal
Measured: 12 mothns
ICU length of stay
Measured: 12 months
Hospital length of stay
Measured: 12 months
Rate of major infections/complications
Measured: 12 months
Rate of in-hospital and 30-day mortality
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start29 Jul 2016
- Primary completion8 Aug 2018
- Study completion8 Aug 2018
Why it stopped: PI relocated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Use of Midodrine in Post-cardiopulmonary Bypass Vasoplegic SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668859
- Sponsor's protocol ID
- 2016-097
- Status last verified
- Jun 2022
- First submitted
- 9 Dec 2020
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midodrine as Novel Treatment of Post-Cardiopulmonary Bypass Vasoplegic Syndrome
- ClinicalTrials.gov ID
- NCT04668859
- Acronym / sponsor ID
- 2016-097
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI relocated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 29 Jul 2016 (actual)
- Primary completion
- 8 Aug 2018 (actual)
- Study completion
- 8 Aug 2018 (actual)
- First posted
- 16 Dec 2020 (actual)
- 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.
Vasoplegic syndrome (VS) is a common and serious complication of cardiopulmonary bypass (CPB) procedures associated with a significant increase in morbidity and mortality. VS is defined as significant hypotension, high or normal cardiac outputs, low systemic vascular resistance, low cardiac filling pressures, and vasopressor requirement despite adequate fluid resuscitation following CPB. Extensive research has been performed regarding the pathophysiologic response to CPB and risk factors associated with VS. No safe and effective preventive strategy has gained widespread use. Supportive care with intravenous (IV) vasopressors has thus been adopted as standard of care. The use of these medications, while effective in the majority of patients, generally necessitates close monitoring in an intensive care unit (ICU) setting. These patients are subject to prolonged ICU and hospital stays, as well as the potential complications of prolonged use of central venous lines (CVL) required to give these medications. Recent studies suggest midodrine, a generic oral vasopressor, may accelerate the decline in IV vasopressor requirements in select ICU patients. At our institution, the addition of midodrine to IV vasopressors for the treatment of VS has been observed to be effective in reducing IV vasopressor duration. No literature exists describing the use of midodrine in this patient population. The goal of this study is to investigate the novel use of midodrine in CPB surgery complicated by VS. Ultimately, we hope to produce literature supporting its use that may be applied on a global scale to improve patient care
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 Arm | Active comparator | Drug: MidodrinePatients will receive the drug Midodrine |
| Placebo Arm | Placebo comparator | Drug: MethylcellulosePatients will receive placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- post-cardiopulmonary bypass surgery
- vasoplegic syndrome criteria
- vasopressor requirement
Key exclusion criteria (11 listed)
- allergy to midodrine
- pregnancy
- midodrine or cardiac glycoside as preadmission medication
- history of orthostatic hypotension, thyrotoxicosis, or pheochromocytoma
- severe organic heart disease (endocarditis, untreated congenital or rheumatic heart disease)
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 |
|---|---|---|
| MidodrineOral vasoactive that is metabolized by the liver an peripheral tissues into desglymidodrine, an active metabolite. It produces arteriolar and venous constriction with a subsequent elevation in blood pressure. | Drug | Midodrine Arm |
| MethylcellulosePlacebo will consist of inert methylcellulose | Drug | Placebo Arm |
Primary outcome
Time from procedure end until discontinuation of IV vasopressors
Time frame: 12 months
6 secondary outcomes
Rate of decline in IV vasopressor dose
Time frame: 12 months
Time until CVL removal
Time frame: 12 mothns
ICU length of stay
Time frame: 12 months
Hospital length of stay
Time frame: 12 months
Rate of major infections/complications
Time frame: 12 months
Rate of in-hospital and 30-day mortality
Time frame: 12 months
Results and safety
The study was stopped early (reason given: PI relocated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Individual participant dataSharing planned: No
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 and Methylcellulose in people with Use of Midodrine in Post-cardiopulmonary Bypass Vasoplegic Syndrome, run by Medstar Health Research Institute.
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 9 inclusion and 11 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: stopped early, as of the sponsor's last update on 1 Jul 2022. 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 stopped early (reason given: PI relocated). Results are not available in the source record.
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 from procedure end until discontinuation of IV vasopressors (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2022; AzTrials last refreshed its copy on 8 Nov 2026.