Orthostatic Hypotension
Conditions
Brief summary
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).
Interventions
DRUGMidodrine
10 mg, p.o., once, on day of surgery after first physical therapy session
OTHERIntravenous fluid bolus
15 cc/kg, once, on day of surgery after first physical therapy session
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients of participating surgeons undergoing unilateral primary total hip arthroplasty * Ages 18-90 * English-speaking * If the patients are diagnosed with orthostatic hypotension (fall in SBP of at least 20 mmHg or DBP of at least 10 mmHg within 3 min of assuming a sitting/standing position)
Exclusion criteria
* Body mass index \> 40 * Low ejection fraction (\<50%) * Clinical diagnosis of congestive heart failure * Aortic insufficiency characterized as greater than moderate * Severe uncontrolled hypertension * Symptomatic bradycardia (HR \< 50 bpm and symptoms) * Creatinine \> 1.2 mg/dl * Hepatic insufficiency * Severe respiratory disease in which supplemental oxygen is required * History of severe urinary retention * Use of MAO inhibitors * Severe supine hypertension (SBP \>= 150 mmHg or DBP \>= 90 mmHg) * History of visual problems and using fludrocortisone acetate * Contraindication for repeated BP measurements * Revision THA and additional procedures * Clonidine use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Orthostatic Hypotension Questionnaire Score | From baseline assessment to post-intervention (30 min, 1 hr, 2 hrs, 3 hrs, 4 hrs) |
Secondary
| Measure | Time frame |
|---|---|
| Length of Stay | Length of the hospital stay (average of 4 days) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 5 |
| 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 | 4 |
| Control (no Intervention) Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions. | 4 |
| Total | 13 |
Baseline characteristics
| Characteristic | Intravenous Fluid Bolus | Control (no Intervention) | Total | Midodrine |
|---|---|---|---|---|
| Age, Continuous | 55.7 years STANDARD_DEVIATION 11.2 | 57.7 years STANDARD_DEVIATION 11.2 | 55.9 years STANDARD_DEVIATION 11.2 | 54.6 years STANDARD_DEVIATION 11.3 |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment United States | 4 participants | 4 participants | 13 participants | 5 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 7 Participants | 3 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 6 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 | 0 / 4 |
Outcome results
Primary
Change in Orthostatic Hypotension Questionnaire Score
Time frame: From baseline assessment to post-intervention (30 min, 1 hr, 2 hrs, 3 hrs, 4 hrs)
Population: DATA WAS NOT COLLECTED. STUDY TERMINATED EARLY.
| Arm | Measure | Value |
|---|---|---|
| Midodrine | Change in Orthostatic Hypotension Questionnaire Score | 0 |
| Intravenous Fluid Bolus | Change in Orthostatic Hypotension Questionnaire Score | 0 |
| Control (no Intervention) | Change in Orthostatic Hypotension Questionnaire Score | 0 |
Secondary
Length of Stay
Time frame: Length of the hospital stay (average of 4 days)
Population: DATA WAS NOT COLLECTED. STUDY TERMINATED EARLY.
| Arm | Measure | Value |
|---|---|---|
| Midodrine | Length of Stay | 0 |
| Intravenous Fluid Bolus | Length of Stay | 0 |
| Control (no Intervention) | Length of Stay | 0 |