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

Orthostatic Hypotension Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02154243
• Other study ID #: 2013-114
• Status: Terminated
• Phase: N/A
• First received: May 28, 2014
• Last updated: July 27, 2017
• Start date: June 2014
• Est. completion date: January 2015

Study information

• Verified date: July 2017
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension
• Signs and Symptoms

Intervention

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

Other:
• Intravenous fluid bolus
15 cc/kg, once, on day of surgery after first physical therapy session

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Orthostatic Hypotension Questionnaire Score		From baseline assessment to post-intervention (30 min, 1 hr, 2 hrs, 3 hrs, 4 hrs)
Secondary	Length of Stay		Length of the hospital stay (average of 4 days)