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Orthostatic hypotension following total hip arthroplasty is known to limit the ability of patients to perform physical therapy (PT) and increase the length of hospital stay and costs. Our goal is to prospectively study the effects of oral midodrine on the signs and symptoms of orthostatic hypotension in 20 patients and the effects of intravenous fluid on the signs of symptoms of orthostatic hypotension in 10 patients. Midodrine will be administered to patients with suspected low SVV, and an intravenous fluid bolus will be administered to patients with low CO. 120 patients will be consented with a view to studying 30 patients who meet the inclusion criteria for orthostatic hypotension. Patients who receive midodrine or the fluid bolus will undergo hemodynamic measurements at 30 min, 1 hr, 2 hrs, 3 hrs, and 4 hrs post-intervention. All patients will undergo measurements for blood pressure, arterial augmentation index, and heart rate at baseline (pre-op; holding area) and the time of first PT attempt. Patients will be monitored up to post-operative day 3. The working hypothesis is that midodrine or fluid therapy will significantly raise the mean arterial blood pressure (MAP) by 5 mmHg+ and/or cause a significant change in the Orthostatic Hypotension Questionnaire (characterized by a two-point improvement in symptom score).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midodrine | Experimental | Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV<15 will be given oral midodrine, 10 mg, once. |
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| Intravenous fluid bolus | Experimental | Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV>=15 will be given intravenous fluid bolus, 15 cc/kg, once. |
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| Control (no intervention) | No Intervention | Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midodrine | Drug | 10 mg, p.o., once, on day of surgery after first physical therapy session |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Orthostatic Hypotension Questionnaire Score | From baseline assessment to post-intervention (30 min, 1 hr, 2 hrs, 3 hrs, 4 hrs) |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | Length of the hospital stay (average of 4 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Midodrine | Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV<15 will be given oral midodrine, 10 mg, once. Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session |
| FG001 | Intravenous Fluid Bolus |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Intravenous fluid bolus | Other | 15 cc/kg, once, on day of surgery after first physical therapy session |
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Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV>=15 will be given intravenous fluid bolus, 15 cc/kg, once. Intravenous fluid bolus: 15 cc/kg, once, on day of surgery after first physical therapy session |
| FG002 | Control (no Intervention) | Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Midodrine | Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV<15 will be given oral midodrine, 10 mg, once. Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session |
| BG001 | Intravenous Fluid Bolus | Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV>=15 will be given intravenous fluid bolus, 15 cc/kg, once. Intravenous fluid bolus: 15 cc/kg, once, on day of surgery after first physical therapy session |
| BG002 | Control (no Intervention) | Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Change in Orthostatic Hypotension Questionnaire Score | DATA WAS NOT COLLECTED. STUDY TERMINATED EARLY. | Posted | From baseline assessment to post-intervention (30 min, 1 hr, 2 hrs, 3 hrs, 4 hrs) |
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| Secondary | Length of Stay | DATA WAS NOT COLLECTED. STUDY TERMINATED EARLY. | Posted | Length of the hospital stay (average of 4 days) |
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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 | Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV<15 will be given oral midodrine, 10 mg, once. Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session | 0 | 5 | 0 | 5 | ||
| EG001 | Intravenous Fluid Bolus | Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV>=15 will be given intravenous fluid bolus, 15 cc/kg, once. Intravenous fluid bolus: 15 cc/kg, once, on day of surgery after first physical therapy session | 0 | 4 | 0 | 4 | ||
| EG002 | Control (no Intervention) | Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions. | 0 | 4 | 0 | 4 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Haskins | HSS | (212) 606-1000 | HaskinsS@hss.edu |
| ID | Term |
|---|---|
| D007024 | Hypotension, Orthostatic |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007022 | Hypotension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008879 | Midodrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
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