An Open Label Trial to Decrease Signs and Symptoms of Orthostatic Hypotension Using Midodrine or Intravenous Fluid Bolus in Patients Following Total Hip Arthroplasty
Primary Purpose
Orthostatic Hypotension
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Midodrine
Intravenous fluid bolus
Sponsored by
About this trial
This is an interventional treatment trial for Orthostatic Hypotension
Eligibility Criteria
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
Sites / Locations
- Hospital for Special Surgery
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Midodrine
Intravenous fluid bolus
Control (no intervention)
Arm Description
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.
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.
Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.
Outcomes
Primary Outcome Measures
Change in Orthostatic Hypotension Questionnaire Score
Secondary Outcome Measures
Length of Stay
Full Information
NCT ID
NCT02154243
First Posted
May 28, 2014
Last Updated
July 27, 2017
Sponsor
Hospital for Special Surgery, New York
1. Study Identification
Unique Protocol Identification Number
NCT02154243
Brief Title
An Open Label Trial to Decrease Signs and Symptoms of Orthostatic Hypotension Using Midodrine or Intravenous Fluid Bolus in Patients Following Total Hip Arthroplasty
Official Title
An Open Label Trial to Decrease Signs and Symptoms of Orthostatic Hypotension Using Midodrine in Patients With Preserved Cardiac Output (CO) and an Intravenous Fluid Bolus for Patients With Low CO Following Total Hip Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Study Start Date
June 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthostatic Hypotension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Midodrine
Arm Type
Experimental
Arm Description
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.
Arm Title
Intravenous fluid bolus
Arm Type
Experimental
Arm Description
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.
Arm Title
Control (no intervention)
Arm Type
No Intervention
Arm Description
Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.
Intervention Type
Drug
Intervention Name(s)
Midodrine
Other Intervention Name(s)
ProAmatine
Intervention Description
10 mg, p.o., once, on day of surgery after first physical therapy session
Intervention Type
Other
Intervention Name(s)
Intravenous fluid bolus
Intervention Description
15 cc/kg, once, on day of surgery after first physical therapy session
Primary Outcome Measure Information:
Title
Change in Orthostatic Hypotension Questionnaire Score
Time Frame
From baseline assessment to post-intervention (30 min, 1 hr, 2 hrs, 3 hrs, 4 hrs)
Secondary Outcome Measure Information:
Title
Length of Stay
Time Frame
Length of the hospital stay (average of 4 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Open Label Trial to Decrease Signs and Symptoms of Orthostatic Hypotension Using Midodrine or Intravenous Fluid Bolus in Patients Following Total Hip Arthroplasty
We'll reach out to this number within 24 hrs