An Open Label Trial to Decrease Signs and Symptoms of Orthostatic Hypotension Using Midodrine or Intravenous Fluid Bolus in Patients Following Total Hip Arthroplasty

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).

Study Overview

• Status: Terminated
• Conditions: Orthostatic Hypotension
• Intervention / Treatment: Drug: Midodrine; Other: Intravenous fluid bolus

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Midodrine; 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.	Drug: Midodrine; 10 mg, p.o., once, on day of surgery after first physical therapy session; Other Names: ProAmatine
Experimental: Intravenous fluid bolus; 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.	Other: Intravenous fluid bolus; 15 cc/kg, once, on day of surgery after first physical therapy session
No Intervention: Control (no intervention); Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Orthostatic Hypotension Questionnaire Score	From baseline assessment to post-intervention (30 min, 1 hr, 2 hrs, 3 hrs, 4 hrs)

Secondary Outcome Measures

Outcome Measure	Time Frame
Length of Stay	Length of the hospital stay (average of 4 days)

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: May 28, 2014
• First Submitted That Met QC Criteria: May 30, 2014
• First Posted (Estimate): June 3, 2014

Study Record Updates

• Last Update Posted (Actual): July 31, 2017
• Last Update Submitted That Met QC Criteria: July 27, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Autonomic Nervous System Diseases; Primary Dysautonomias; Orthostatic Intolerance; Hypotension; Hypotension, Orthostatic; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympathomimetics; Vasoconstrictor Agents; Adrenergic alpha-1 Receptor Agonists; Midodrine
• Other Study ID Numbers: 2013-114