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Trial · NCT01531959

Midodrine for the Treatment of Refractory Hypotension

NCT01531959, Phase 3, Completed, Massachusetts General Hospital; results first posted 2019-09-06

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Midodrine for the Treatment of Refractory Hypotension. Trials, record NCT01531959. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01531959

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Midodrine for the Treatment of Refractory Hypotension
NCT number
NCT01531959
Status
Completed
Phases
Phase 3
Enrollment
139 participants, actual
Lead sponsor
Massachusetts General Hospital
Conditions
Hypotension, Critical Illness
Interventions
Midodrine, Placebo
First posted
2012-02-13
Last updated
2020-10-28
Results first posted
2019-09-06

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryTime Until Discontinuation of IV VasopressorsFrom initiation of the study drug until discontinuation of IV vasopressors, assessed up to 400 hoursMeasured hours from initiation of midodrine until discontinuation of IV vasopressors
SecondaryICU Length of StayFrom initiation of midodrine until ICU discharge, assessed up to 45 daysMeasured number of days from initiation of midodrine until discharge ready from the ICU
SecondaryHospital Length of StayFrom initiation of midodrine until hospital discharge, assessed up to 90 daysMeasured number of days from initiation of midodrine until discharged from hospital
SecondaryRates of ICU ReadmissionUp to 2 months after ICU dischargeNumber of patients initiated on midodrine that are readmitted back to ICU after being discharged to floor
SecondaryRates of Hypertension, Bradycardia, and Hemodynamically Significant TacharrythmiasFrom initiation of the study drug until discontinuation of the study drug, an average of 59 hours.
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).

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYTime Until Discontinuation of IV VasopressorsFrom initiation of the study drug until discontinuation of IV vasopressors, assessed up to 400 hourshoursMEDIAN
SECONDARYICU Length of StayFrom initiation of midodrine until ICU discharge, assessed up to 45 daysdaysMEDIAN
SECONDARYHospital Length of StayFrom initiation of midodrine until hospital discharge, assessed up to 90 daysdaysMEDIAN
SECONDARYRates of ICU ReadmissionUp to 2 months after ICU dischargeParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYRates of Hypertension, Bradycardia, and Hemodynamically Significant TacharrythmiasFrom initiation of the study drug until discontinuation of the study drug, an average of 59 hours.ParticipantsCOUNT_OF_PARTICIPANTS

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Time Until Discontinuation of IV VasopressorsMidodrine23.5Inter-Quartile Range 10.0 to 54.0hours
Time Until Discontinuation of IV VasopressorsPlacebo22.5Inter-Quartile Range 10.4 to 40.0hours
ICU Length of StayMidodrine6.0Inter-Quartile Range 5.0 to 8.0days
ICU Length of StayPlacebo6.0Inter-Quartile Range 4.0 to 8.0days
Hospital Length of StayMidodrine11.0Inter-Quartile Range 9.0 to 21.0days
Hospital Length of StayPlacebo14.0Inter-Quartile Range 9.0 to 22.0days
Rates of ICU ReadmissionMidodrine1Participants
Rates of ICU ReadmissionPlacebo3Participants
Rates of Hypertension, Bradycardia, and Hemodynamically Significant TacharrythmiasMidodrine12Participants
Rates of Hypertension, Bradycardia, and Hemodynamically Significant TacharrythmiasPlacebo3Participants

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDMidodrine68
Overall StudySTARTEDPlacebo68
Overall StudyCOMPLETEDMidodrine66
Overall StudyCOMPLETEDPlacebo66
Overall StudyNOT COMPLETEDMidodrine2
Overall StudyNOT COMPLETEDPlacebo2

Adverse events44

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherHypertensionCardiac disordersMidodrine7667
otherHypertensionCardiac disordersPlacebo3663
otherBradycardiaCardiac disordersMidodrine5665
otherBradycardiaCardiac disordersPlacebo0660
otherAtrial fibrillationCardiac disordersMidodrine3663
otherAtrial fibrillationCardiac disordersPlacebo1661
otherNauseaGastrointestinal disordersMidodrine2662
otherNauseaGastrointestinal disordersPlacebo1661
otherLab parameter changeInvestigationsMidodrine2662
otherLab parameter changeInvestigationsPlacebo1661

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityMidodrine066
Total, all-cause mortalityPlacebo166
Total, other adverse eventsMidodrine2066
Total, other adverse eventsPlacebo1766
Total, serious adverse eventsMidodrine066
Total, serious adverse eventsPlacebo166

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
28327122DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Midodrine vs Placebo: Rates of ICU ReadmissionTrial comparisons
Midodrine vs Placebo: deaths from any causeTrial comparisons
Midodrine vs Placebo: Rates of Hypertension, Bradycardia, and Hemodynamically Significant TacharrythmiasTrial comparisons
Midodrine vs Placebo: serious adverse eventsTrial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01531959

GET https://conductscience.org/api/trials/v1/NCT01531959/events?page=2