Clinical 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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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).

Detailed Summary:
Sponsor: Hospital for Special Surgery, New York

Current 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) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Length of stay [ Time Frame: Length of the hospital stay (average of 4 days) ]
  • Orthostatic hypotension/dizziness [ Time Frame: First physical therapy session on the day of surgery (~3-6 hours after surgery) ]
  • Cardiac parameters (BP, AI, CO, HR, SVV) [ Time Frame: Baseline assessment to post-intervention (4 hours after initiation of intervention on the day of surgery) ]
  • Number of attempts at physical therapy [ Time Frame: Length of the hospital stay (average of 4 days) ]
  • Successful physical therapy sessions and milestones [ Time Frame: Length of the hospital stay (average of 4 days) ]
  • Resolution of orthostatic hypotension [ Time Frame: 4 hours post-intervention (after initiation of intervention on the day of surgery) ]


Original Secondary Outcome:

  • Length of stay [ Time Frame: Length of the hospital stay (average of 4 days) ]
  • Orthostatic hypotension/dizziness [ Time Frame: First physical therapy session on the day of surgery (~3-6 hours after surgery) ]
  • Cardiac parameters (BP, AI, CO, HR, SVV, SVR) [ Time Frame: Baseline assessment to post-intervention (4 hours after initiation of intervention on the day of surgery) ]
  • Number of attempts at physical therapy [ Time Frame: Length of the hospital stay (average of 4 days) ]
  • Successful physical therapy sessions and milestones [ Time Frame: Length of the hospital stay (average of 4 days) ]
  • Resolution of orthostatic hypotension [ Time Frame: 4 hours post-intervention (after initiation of intervention on the day of surgery) ]


Information By: Hospital for Special Surgery, New York

Dates:
Date Received: May 28, 2014
Date Started: June 2014
Date Completion:
Last Updated: August 31, 2015
Last Verified: January 2015