Efficacy of Midodrine for the Prevention of Orthostatic Hypotension During Early Mobilization After Fast-track Hip Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-09-30

Brief Summary

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The aim of this study is to examine the efficacy of 5 mg Midodrine (Gutron) vs. placebo on reducing the incidence of orthostatic hypotension during mobilization 6 h after a total hip arthroplasty.

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Detailed Description

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Conditions

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Postoperative Orthostatic Hypotension Postoperative Orthostatic Intolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Midodrine

Midodrine Hydrochloride (5mg) administered as capsule 5 and 23 hours after end of surgery.

Group Type EXPERIMENTAL

Midodrine

Intervention Type DRUG

Midodrine 5mg as capsule, administered twice (5 and 23 hours after end of surgery).

Placebo

Placebo administered as capsule 5- and 23 hours after end of surgery.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsule to mimic midodrine

Interventions

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Midodrine

Midodrine 5mg as capsule, administered twice (5 and 23 hours after end of surgery).

Intervention Type DRUG

Placebo

Placebo capsule to mimic midodrine

Intervention Type DRUG

Other Intervention Names

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Gutron

Eligibility Criteria

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Inclusion Criteria

* Scheduled for primary unilateral hip arthroplasty
* Age \>= 18 years
* Able to give informed consent

Exclusion Criteria

* General anaesthesia for the current procedure
* Digoxin treatment.
* history of renal or hepatic failure
* history of glaucoma
* history chronic urinary retention requiring treatment
* history of orthostatic intolerance / hypotension
* other autonomous nervous system disease
* alcohol or drug abuse
* current malignant disease
* females in the fertile age (possible pregnancy or breast feeding)
* Treatment with anticoagulants
* BMI \> 40 kg/m2
* Dementia or cognitive dysfunction (investigators evaluation)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No