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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-098 | Other Identifier | Sir Charles Gairdner Hospital HREC | |
| 2018P000162 | Other Identifier | Beth Israel Deaconess Medical Center |
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| Name | Class |
|---|---|
| Sir Charles Gairdner Hospital | OTHER |
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We hypothesize that midodrine treatment of refractory hypotension in patients otherwise ready for discharge from the ICU shortens duration of receiving IV vasopressors and SICU length of stay without increasing MGH length of stay or putting the patient at risk of being readmitted to an ICU.
Persistent hypotension in critically ill patients remains a major barrier to discharging patients from the intensive care unit (ICU). In our hospital, in patients with adequate tissue perfusion, midodrine has been observed to treat hypotension in order to wean continuous intravenous (IV) vasopressors and therefore promote ICU discharge. There are several possible etiologies of hypotension in the ICU. The most frequently seen causes include septic shock, hypovolemia, adrenal insufficiency, and idiosyncratic reactions from medications. For patients whose reversible causes of hypotension have been addressed but still require vasopressors, midodrine may prove to be a useful adjunctive medication to successfully increase blood pressure. No previous studies have examined the use of midodrine for the treatment of hypotension in an ICU setting. Therefore, we are investigating a new indication for midodrine as the treatment of hypotension in critically ill patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midodrine | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midodrine | Drug | Patients will be randomized to blinded to 20 mg of midodrine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time Until Discontinuation of IV Vasopressors | Measured hours from initiation of midodrine until discontinuation of IV vasopressors | From initiation of the study drug until discontinuation of IV vasopressors, assessed up to 400 hours |
| Measure | Description | Time Frame |
|---|---|---|
| ICU Length of Stay | Measured number of days from initiation of midodrine until discharge ready from the ICU | From initiation of midodrine until ICU discharge, assessed up to 45 days |
| Hospital Length of Stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Eikermann, MD, PhD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Beth Israel Deaconess Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28327122 | Derived | Anstey MH, Wibrow B, Thevathasan T, Roberts B, Chhangani K, Ng PY, Levine A, DiBiasio A, Sarge T, Eikermann M. Midodrine as adjunctive support for treatment of refractory hypotension in the intensive care unit: a multicenter, randomized, placebo controlled trial (the MIDAS trial). BMC Anesthesiol. 2017 Mar 21;17(1):47. doi: 10.1186/s12871-017-0339-x. |
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139 participants provided informed consent and were enrolled. 3 participants subsequently did no loner meet eligibility criteria and were therefore not randomized, resulting in a total number of started/randomized participants of 136.
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| ID | Title | Description |
|---|---|---|
| FG000 | Midodrine | Midodrine: Patients will be randomized to blinded to 20 mg of midodrine |
| FG001 | Placebo | Placebo: Patients will be randomized to blinded placebo control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Midodrine | Midodrine: Patients will be randomized to blinded to 20 mg of midodrine |
| BG001 | Placebo | Placebo: Patients will be randomized to blinded placebo control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time Until Discontinuation of IV Vasopressors | Measured hours from initiation of midodrine until discontinuation of IV vasopressors | Posted | Median | Inter-Quartile Range | hours | From initiation of the study drug until discontinuation of IV vasopressors, assessed up to 400 hours |
|
Adverse events were collected daily from medical records for the period of study drug administration, an average of 59 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Midodrine | Midodrine: Patients will be randomized to blinded to 20 mg of midodrine |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthias Eikermann | Beth Israel Deaconess Medical Center | 6176327034 | meikerma@bidmc.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 27, 2020 | Aug 25, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D008879 | Midodrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Placebo |
| Drug |
Patients will be randomized to blinded placebo control |
|
Measured number of days from initiation of midodrine until discharged from hospital
| From initiation of midodrine until hospital discharge, assessed up to 90 days |
| Rates of ICU Readmission | Number of patients initiated on midodrine that are readmitted back to ICU after being discharged to floor | Up to 2 months after ICU discharge |
| Rates of Hypertension, Bradycardia, and Hemodynamically Significant Tacharrythmias | 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). | From initiation of the study drug until discontinuation of the study drug, an average of 59 hours. |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 60009 | Australia |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| APACHE II Score | The Acute Physiology and Chronic Health Evaluation (APACHE II) score is an mortality prediction score used in critically ill patients. I ranges from 0 (minimum) to 71 (maximum), with lower score values representing better outcomes. | Mean | Standard Deviation | units on a scale |
|
| SOFA Score on admission day | The Sequential Organ Failure Assessment (SOFA) score is a score that allows for calculation of both the number and the severity of organ dysfunction in six organ systems (respiratory, coagulatory, liver, cardiovascular, renal, and neurologic). I ranges from 0 (minimum) to 24 (maximum), with lower score values representing better outcomes. | Median | Inter-Quartile Range | units on a scale |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | ICU Length of Stay | Measured number of days from initiation of midodrine until discharge ready from the ICU | Posted | Median | Inter-Quartile Range | days | From initiation of midodrine until ICU discharge, assessed up to 45 days |
|
|
|
| Secondary | Hospital Length of Stay | Measured number of days from initiation of midodrine until discharged from hospital | Posted | Median | Inter-Quartile Range | days | From initiation of midodrine until hospital discharge, assessed up to 90 days |
|
|
|
| Secondary | Rates of ICU Readmission | Number of patients initiated on midodrine that are readmitted back to ICU after being discharged to floor | Posted | Count of Participants | Participants | Up to 2 months after ICU discharge |
|
|
|
| Secondary | Rates of Hypertension, Bradycardia, and Hemodynamically Significant Tacharrythmias | 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). | Posted | Count of Participants | Participants | From initiation of the study drug until discontinuation of the study drug, an average of 59 hours. |
|
|
|
| 0 |
| 66 |
| 0 |
| 66 |
| 20 |
| 66 |
| EG001 | Placebo | Placebo: Patients will be randomized to blinded placebo control | 1 | 66 | 1 | 66 | 17 | 66 |
| Bradycardia | Cardiac disorders | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Lab parameter change | Investigations | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
|
| Cough/dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | Non-systematic Assessment |
|
| Myocardial infarction/ischemia | Cardiac disorders | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Peripheral edema | General disorders | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Lightheadedness | Nervous system disorders | Non-systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Ventricular ectopic beats | Cardiac disorders | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Subdural hemtoma | Nervous system disorders | Non-systematic Assessment |
|
| Small bowel obstruction | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |