Orthostatic HypotensionNCT02154243
An Open Label Trial to Decrease Signs and Symptoms of Orthostatic Hypotension Using Midodrine or Intravenous Fluid Bolus in Patients Following Total Hip Arthroplasty
A study testing Midodrine and Intravenous fluid bolus in people with Orthostatic Hypotension, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Orthostatic Hypotension
- What is being tested?
- Midodrine and Intravenous fluid bolus
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
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
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).
- Conditions
- Orthostatic Hypotension
- Being tested
- Midodrine, Intravenous fluid bolus
- Medical subject headings
- Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidodrineDrug
Also called ProAmatine
10 mg, p.o., once, on day of surgery after first physical therapy session
Intravenous fluid bolusOther
15 cc/kg, once, on day of surgery after first physical therapy session
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Midodrine |
| 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. Receives: Other: Intravenous fluid bolus |
| Control (no intervention) | No intervention | Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Orthostatic Hypotension Questionnaire Score
Measured: From baseline assessment to post-intervention (30 min, 1 hr, 2 hrs, 3 hrs, 4 hrs)
Secondary outcomes (1)
Length of Stay
Measured: Length of the hospital stay (average of 4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Orthostatic HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154243
- Sponsor's protocol ID
- 2013-114
- Status last verified
- Jul 2017
- First submitted
- 28 May 2014
- Last updated
- 31 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02154243
- Acronym / sponsor ID
- 2013-114
- Conditions
- Orthostatic Hypotension
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Posted 31 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Midodrine | Experimental | Drug: MidodrinePatients 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. |
| Intravenous fluid bolus | Experimental | Other: Intravenous fluid bolusPatients 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. |
| Control (no intervention) | No intervention | –Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (16 listed)
- Body mass index > 40
- Low ejection fraction (<50%)
- Clinical diagnosis of congestive heart failure
- Aortic insufficiency characterized as greater than moderate
- Severe uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidodrineAlso: ProAmatine10 mg, p.o., once, on day of surgery after first physical therapy session | Drug | Midodrine |
| Intravenous fluid bolus15 cc/kg, once, on day of surgery after first physical therapy session | Other | Intravenous fluid bolus |
Primary outcome
Change in Orthostatic Hypotension Questionnaire Score
Time frame: From baseline assessment to post-intervention (30 min, 1 hr, 2 hrs, 3 hrs, 4 hrs)
1 secondary outcome
Length of Stay
Time frame: Length of the hospital stay (average of 4 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midodrine and Intravenous fluid bolus in people with Orthostatic Hypotension, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Orthostatic Hypotension Questionnaire Score (time frame: From baseline assessment to post-intervention (30 min, 1 hr, 2 hrs, 3 hrs, 4 hrs)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2017; AzTrials last refreshed its copy on 27 Oct 2026.