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

• Sponsor: Hospital for Special Surgery, New York (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02154243
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Arms: 3
• Duration (Months): 7
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Orthostatic Hypotension	Drug: Midodrine; Other: Intravenous fluid bolus	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Length of Stay [Length of the hospital stay (average of 4 days)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital for Special Surgery	New York	New York	United States	10021

Sponsors and Collaborators

• Hospital for Special Surgery, New York

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospital for Special Surgery, New York
• ClinicalTrials.gov Identifier: NCT02154243
• Other Study ID Numbers: 2013-114
• First Posted: Jun 3, 2014
• Last Update Posted: Jul 31, 2017
• Last Verified: Jul 1, 2017

• Additional relevant MeSH terms: Hypotension, Orthostatic; Hypotension; Midodrine

Study Results

Participant Flow

Arm/Group Title	Midodrine	Intravenous Fluid Bolus	Control (no Intervention)
Arm/Group Description	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. Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session	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. Intravenous fluid bolus: 15 cc/kg, once, on day of surgery after first physical therapy session	Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.
Period Title: Overall Study
STARTED	5	4	4
COMPLETED	5	4	4
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Midodrine	Intravenous Fluid Bolus	Control (no Intervention)	Total
Arm/Group Description	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. Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session	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. Intravenous fluid bolus: 15 cc/kg, once, on day of surgery after first physical therapy session	Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.	Total of all reporting groups
Overall Participants	5	4	4	13
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.6 (11.3)	55.7 (11.2)	57.7 (11.2)	55.9 (11.2)
Sex: Female, Male (Count of Participants)
Female	3 60%	2 50%	2 50%	7 53.8%
Male	2 40%	2 50%	2 50%	6 46.2%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	5 100%	4 100%	4 100%	13 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

DATA WAS NOT COLLECTED. STUDY TERMINATED EARLY.

Arm/Group Title	Midodrine	Intravenous Fluid Bolus	Control (no Intervention)
Arm/Group Description	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. Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session	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. Intravenous fluid bolus: 15 cc/kg, once, on day of surgery after first physical therapy session	Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.
Measure Participants	0	0	0
	0	0	0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

DATA WAS NOT COLLECTED. STUDY TERMINATED EARLY.

Arm/Group Title	Midodrine	Intravenous Fluid Bolus	Control (no Intervention)
Arm/Group Description	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. Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session	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. Intravenous fluid bolus: 15 cc/kg, once, on day of surgery after first physical therapy session	Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.
Measure Participants	0	0	0
	0	0	0

Adverse Events

Arm/Group Title	Midodrine		Intravenous Fluid Bolus		Control (no Intervention)
Arm/Group Description	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. Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session		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. Intravenous fluid bolus: 15 cc/kg, once, on day of surgery after first physical therapy session		Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.
All Cause Mortality
	Midodrine		Intravenous Fluid Bolus		Control (no Intervention)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Midodrine		Intravenous Fluid Bolus		Control (no Intervention)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/4 (0%)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	Midodrine		Intravenous Fluid Bolus		Control (no Intervention)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/4 (0%)		0/4 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.