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NCT02154243 · ClinicalTrials.gov registry record · NA
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 NA study, sponsored by Hospital for Special Surgery, New York.
- Terminated
- Registry status
- NA
- Development phase
- 13
- Enrollment target
NCT02154243 is a NA study that was terminated before completion, run by Hospital for Special Surgery, New York. The registered enrollment target is 13 participants.
The verdict
NCT02154243, a NA study, was terminated before completion, sponsored by Hospital for Special Surgery, New York.
- TERMINATED
- Registry status
- NA
- Development phase
- 13 participants
- Enrollment target
Study 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
- DRUG Midodrine
- OTHER Intravenous fluid bolus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2014-06 |
| Est. Completion | 2015-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02154243
The ClinicalTrials.gov registry entry for NCT02154243 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hospital for Special Surgery, New York, which has 194 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Midodrine is the first listed.
NCT02154243 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02154243 about?
NCT02154243 is a clinical study titled "An Open Label Trial to Decrease Signs and Symptoms of Orthostatic Hypotension Using Midodrine or Intravenous Fluid Bolus in Patients 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 hypotensio...
What is the current status of trial NCT02154243?
This trial is currently terminated. It is a NA study. The enrollment target is 13 participants. The study started on 2014-06. Estimated completion is 2015-01.
What interventions are being tested in trial NCT02154243?
The interventions under investigation include: Midodrine (DRUG), Intravenous fluid bolus (OTHER).
Who is sponsoring clinical trial NCT02154243?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
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