Ignite Creation Date:
2024-05-06 @ 2:55 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02154243
Status:
TERMINATED
Last Update Posted:
2017-07-31
First Post:
2014-05-28
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
Sponsor:
Hospital for Special Surgery New York
Organization:
Hospital for Special Surgery New York
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor cause a significant change in the Orthostatic Hypotension Questionnaire characterized by a two-point improvement in symptom score
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None