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

NCT ID: NCT02154243

Last Updated: 2017-07-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-01-31

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).

Conditions

Orthostatic Hypotension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Midodrine

Intervention Type: DRUG

10 mg, p.o., once, on day of surgery after first physical therapy session

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.

Group Type: EXPERIMENTAL

Intravenous fluid bolus

Intervention Type: OTHER

15 cc/kg, once, on day of surgery after first physical therapy session

Control (no intervention)

Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Midodrine

10 mg, p.o., once, on day of surgery after first physical therapy session

Intervention Type: DRUG

Intravenous fluid bolus

15 cc/kg, once, on day of surgery after first physical therapy session

Intervention Type: OTHER

Other Intervention Names

ProAmatine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital for Special Surgery

New York, New York, United States

Countries

United States

Other Identifiers

2013-114

Identifier Type: -

Identifier Source: org_study_id