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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time Until Discontinuation of IV Vasopressors | 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 |
| Secondary | ICU Length of Stay | From initiation of midodrine until ICU discharge, assessed up to 45 days | Measured number of days from initiation of midodrine until discharge ready from the ICU |
| Secondary | Hospital Length of Stay | From initiation of midodrine until hospital discharge, assessed up to 90 days | Measured number of days from initiation of midodrine until discharged from hospital |
| Secondary | Rates of ICU Readmission | Up to 2 months after ICU discharge | Number of patients initiated on midodrine that are readmitted back to ICU after being discharged to floor |
| Secondary | Rates of Hypertension, Bradycardia, and Hemodynamically Significant Tacharrythmias | From 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). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time Until Discontinuation of IV Vasopressors | From initiation of the study drug until discontinuation of IV vasopressors, assessed up to 400 hours | hours | MEDIAN | |
| SECONDARY | ICU Length of Stay | From initiation of midodrine until ICU discharge, assessed up to 45 days | days | MEDIAN | |
| SECONDARY | Hospital Length of Stay | From initiation of midodrine until hospital discharge, assessed up to 90 days | days | MEDIAN | |
| SECONDARY | Rates of ICU Readmission | Up to 2 months after ICU discharge | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Rates of Hypertension, Bradycardia, and Hemodynamically Significant Tacharrythmias | From initiation of the study drug until discontinuation of the study drug, an average of 59 hours. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time Until Discontinuation of IV Vasopressors | Midodrine | 23.5 | Inter-Quartile Range 10.0 to 54.0 | hours | |
| Time Until Discontinuation of IV Vasopressors | Placebo | 22.5 | Inter-Quartile Range 10.4 to 40.0 | hours | |
| ICU Length of Stay | Midodrine | 6.0 | Inter-Quartile Range 5.0 to 8.0 | days | |
| ICU Length of Stay | Placebo | 6.0 | Inter-Quartile Range 4.0 to 8.0 | days | |
| Hospital Length of Stay | Midodrine | 11.0 | Inter-Quartile Range 9.0 to 21.0 | days | |
| Hospital Length of Stay | Placebo | 14.0 | Inter-Quartile Range 9.0 to 22.0 | days | |
| Rates of ICU Readmission | Midodrine | 1 | Participants | ||
| Rates of ICU Readmission | Placebo | 3 | Participants | ||
| Rates of Hypertension, Bradycardia, and Hemodynamically Significant Tacharrythmias | Midodrine | 12 | Participants | ||
| Rates of Hypertension, Bradycardia, and Hemodynamically Significant Tacharrythmias | Placebo | 3 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Midodrine | 68 | |
| Overall Study | STARTED | Placebo | 68 | |
| Overall Study | COMPLETED | Midodrine | 66 | |
| Overall Study | COMPLETED | Placebo | 66 | |
| Overall Study | NOT COMPLETED | Midodrine | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events44
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypertension | Cardiac disorders | Midodrine | 7 | 66 | 7 |
| other | Hypertension | Cardiac disorders | Placebo | 3 | 66 | 3 |
| other | Bradycardia | Cardiac disorders | Midodrine | 5 | 66 | 5 |
| other | Bradycardia | Cardiac disorders | Placebo | 0 | 66 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Midodrine | 3 | 66 | 3 |
| other | Atrial fibrillation | Cardiac disorders | Placebo | 1 | 66 | 1 |
| other | Nausea | Gastrointestinal disorders | Midodrine | 2 | 66 | 2 |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 66 | 1 |
| other | Lab parameter change | Investigations | Midodrine | 2 | 66 | 2 |
| other | Lab parameter change | Investigations | Placebo | 1 | 66 | 1 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Midodrine | 0 | 66 |
| Total, all-cause mortality | Placebo | 1 | 66 |
| Total, other adverse events | Midodrine | 20 | 66 |
| Total, other adverse events | Placebo | 17 | 66 |
| Total, serious adverse events | Midodrine | 0 | 66 |
| Total, serious adverse events | Placebo | 1 | 66 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28327122 | DERIVED |
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.
| Comparison | Source |
|---|---|
| Midodrine vs Placebo: Rates of ICU Readmission | Trial comparisons |
| Midodrine vs Placebo: deaths from any cause | Trial comparisons |
| Midodrine vs Placebo: Rates of Hypertension, Bradycardia, and Hemodynamically Significant Tacharrythmias | Trial comparisons |
| Midodrine vs Placebo: serious adverse events | Trial 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.
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