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

Phase 3

Completed

• Conditions: Postoperative Orthostatic Hypotension; Postoperative Orthostatic Intolerance
• Interventions: Drug: Placebo; Drug: Midodrine

• Registration Number: NCT01707953
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-10
• Study First Submitted QC: 2012-10-15
• Study First Posted: 2012-10-16
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-17
• Last Update Posted: 2014-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo administered as capsule 5- and 23 hours after end of surgery.
Midodrine	Midodrine	Midodrine Hydrochloride (5mg) administered as capsule 5 and 23 hours after end of surgery.

Primary Outcome Measures

Name	Time	Method
Orthostatic hypotension	6 hours after surgery	Orthostatic hypotension (OH) during early mobilization 6 hours after end of surgery. OH is classified according to international consensus.

Secondary Outcome Measures

Name	Time	Method
Orthostatic hypotension 24 hours after surgery	24 hours after end of surgery.
Orthostatic Intolerance	6 and 24 hours after end of surgery	Orthostatic intolerance is defined as subjective presyncopal symptoms (dizziness, nausea etc.) during mobilization after surgery
Treatment side effects	6 and 24 hours after end of surgery	The following side effects to Midodrine are evaluated: * Pruritus; * Headache; * Supine hypertension; * Urinary retention

Trial Locations

Locations (3)

Gentofte Hospital, Department of orthopaedic surgery; 🇩🇰 Hellerup, Denmark

Hvidovre Hospital, Department of orthopaedic surgery; 🇩🇰 Hvidovre, Denmark

Vejle Sygehus, Department of orthopedic surgery; 🇩🇰 Vejle, Denmark