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

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT01707953

Collaborator

(none)

120

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Orthostatic Hypotension Postoperative Orthostatic Intolerance	Drug: Midodrine Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Efficacy of Midodrine for the Prevention of Orthostatic Hypotension During Early Mobilization After Fast-track Hip Arthroplasty - a Randomized, Placebo Controlled Trial.

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Midodrine Midodrine Hydrochloride (5mg) administered as capsule 5 and 23 hours after end of surgery.	Drug: Midodrine Midodrine 5mg as capsule, administered twice (5 and 23 hours after end of surgery). Other Names: Gutron
Placebo Comparator: Placebo Placebo administered as capsule 5- and 23 hours after end of surgery.	Drug: Placebo Placebo capsule to mimic midodrine

Arm

Intervention/Treatment

Experimental: Midodrine

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

Drug: Midodrine

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

Other Names:

Gutron

Placebo Comparator: Placebo

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

Drug: Placebo

Placebo capsule to mimic midodrine

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Haemodynamic response to mobilization 6 and 24 hours after surgery [6 and 24 hours after end of surgery]
Haemodynamic response to mobilization (supine, sitting and standing): Response in systolic and diastolic blood pressure Response in heart rate. Response in calculated haemodynamic variables (stroke volume, peripheral resistance)
Heart rate variability [before surgery, 6- and 24 hours after surgery]
Heart rate variability measures including spectral analysis and LF/HF ratio at rest and during mobilization.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Gentofte Hospital, Department of orthopaedic surgery	Hellerup	Denmark	2900
2	Hvidovre Hospital, Department of orthopaedic surgery	Hvidovre	Denmark	2650
3	Vejle Sygehus, Department of orthopedic surgery	Vejle	Denmark	7100

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Study Chair: Henrik Kehlet, Proffessor, Rigshospitalet, Section for Surgical Pathophysiology
Study Director: Oeivind Jans, M.D., Rigshospitalet, Section for Surgical Pathophysiology