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

NCT02154243 | Terminated Results

• 1 other identifier: 2013-114
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Orthostatic Hypotension Questionnaire Score

  From baseline assessment to post-intervention (30 min, 1 hr, 2 hrs, 3 hrs, 4 hrs)

Secondary Outcomes (1)

• Length of Stay

  Length of the hospital stay (average of 4 days)

Study Arms (3)

Midodrine

EXPERIMENTAL

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

Intravenous fluid bolus

EXPERIMENTAL

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

Control (no intervention)

NO INTERVENTION

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

Interventions

Midodrine DRUG

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

Also known as: ProAmatine

Midodrine

Intravenous fluid bolus OTHER

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

Intravenous fluid bolus

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Hypotension, Orthostatic

Interventions

Midodrine

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Results Point of Contact

• Title: Dr. Haskins
• Organization: HSS

HaskinsS@hss.edu

(212) 606-1000

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: June 3, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: July 31, 2017
• Results First Posted: July 31, 2017

Record last verified: 2017-07

Locations

US (1)