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TerminatedNCT04668859Updated Jul 1, 2022

Midodrine as Novel Treatment of Post-Cardiopulmonary Bypass Vasoplegic Syndrome

A Phase 4 interventional study of Midodrine and Methylcellulose in Use of Midodrine in Post-cardiopulmonary Bypass Vasoplegic Syndrome, sponsored by Medstar Health Research Institute. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-01.

Sponsored by Medstar Health Research Institute · Phase 4, Interventional, and Treatment

Why this study was terminated
PI relocated

From the registry’s dates

  • Primary completion was Aug 2018, 8 years 3 months ago, and no results have been posted to the registry.
  • Registered 4 years 4 months after the study started (first participant enrolled Jul 2016, registered Dec 2020).
Phase
Phase 4
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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

02

Conditions studied

  • Use of Midodrine in Post-cardiopulmonary Bypass Vasoplegic Syndrome

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03

In context

Vasoplegia

48 studies on the registry are indexed under Vasoplegia; 19 are open to participants now.

This study's enrollment of 10 is below the median of 110 across 27 interventional studies indexed under Vasoplegia.

Browse Vasoplegia studies →

Lead sponsor

Medstar Health Research Institute is the lead sponsor of 161 studies on the registry; 31 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 7 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • post-cardiopulmonary bypass surgery
  • vasoplegic syndrome criteria

    1. MAP \< 65mmHg
    2. Cardiac index>/=2.4 L/min/m\^2, as determined by Swan-
    3. systemic vascular resistance index \</=1400 dynes s/cm\^5/m\^2
    4. adequate fluid resuscitation as determined by treating critical care team
  • vasopressor requirement

    1. norepinephrine 0.05-0.5 mcg/kg/min WITH/WITHOUT
    2. vasopressin any dose

Exclusion criteria

Exclusion Criteria:

  • 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
  • chronic kidney disease ( \<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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
10 participants (actual)

Study arms

  • Active comparator
    Midodrine Arm

    Patients will receive the drug Midodrine

    Drug: Midodrine

  • Placebo comparator
    Placebo Arm

    Patients will receive placebo.

    Drug: Methylcellulose

Interventions

  • 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.

  • DrugMethylcellulose

    Placebo will consist of inert methylcellulose

06

What researchers measure

Primary outcomes

  1. Time from procedure end until discontinuation of IV vasopressors

    Time frame: 12 months

Secondary outcomes

  1. Rate of decline in IV vasopressor dose

    Time frame: 12 months

  2. Time until CVL removal

    Time frame: 12 mothns

  3. ICU length of stay

    Time frame: 12 months

  4. Hospital length of stay

    Time frame: 12 months

  5. Rate of major infections/complications

    Time frame: 12 months

  6. Rate of in-hospital and 30-day mortality

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2016 to primary completion in Aug 2018, 24 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 9, 2020
First posted
Dec 16, 2020
StartActual
Jul 29, 2016
Primary completionActual
Aug 8, 2018
CompletionActual
Aug 8, 2018
Last update
Jul 1, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04668859
Responsible party
Sponsor
First posted
Dec 16, 2020
Start date
Jul 29, 2016
Primary completion
Aug 8, 2018
Completion
Aug 8, 2018
Last update
Jul 1, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Midodrine

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