Efficacy of Midodrine for the Prevention of Orthostatic Hypotension During Early Mobilization After Fast-track Hip Arthroplasty
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.
Postoperative Orthostatic Hypotension
Postoperative Orthostatic Intolerance
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.|
- Orthostatic hypotension [ Time Frame: 6 hours after surgery ] [ Designated as safety issue: No ]Orthostatic hypotension (OH) during early mobilization 6 hours after end of surgery. OH is classified according to international consensus.
- Orthostatic hypotension 24 hours after surgery [ Time Frame: 24 hours after end of surgery. ] [ Designated as safety issue: No ]
- Orthostatic Intolerance [ Time Frame: 6 and 24 hours after end of surgery ] [ Designated as safety issue: No ]Orthostatic intolerance is defined as subjective presyncopal symptoms (dizziness, nausea etc.) during mobilization after surgery
- Treatment side effects [ Time Frame: 6 and 24 hours after end of surgery ] [ Designated as safety issue: Yes ]
The following side effects to Midodrine are evaluated:
- Supine hypertension
- Urinary retention
- Haemodynamic response to mobilization 6 and 24 hours after surgery [ Time Frame: 6 and 24 hours after end of surgery ] [ Designated as safety issue: No ]
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 [ Time Frame: before surgery, 6- and 24 hours after surgery ] [ Designated as safety issue: No ]Heart rate variability measures including spectral analysis and LF/HF ratio at rest and during mobilization.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Midodrine Hydrochloride (5mg) administered as capsule 5 and 23 hours after end of surgery.
Midodrine 5mg as capsule, administered twice (5 and 23 hours after end of surgery).
Other Name: Gutron
Placebo Comparator: Placebo
Placebo administered as capsule 5- and 23 hours after end of surgery.
Placebo capsule to mimic midodrine
|Contact: Oeivind Jans, M.D.||+email@example.com|
|Gentofte Hospital, Department of orthopaedic surgery||Recruiting|
|Hellerup, Denmark, 2900|
|Contact: Søren Solgaard firstname.lastname@example.org|
|Principal Investigator: Søren Solgaard|
|Hvidovre Hospital, Department of orthopaedic surgery||Recruiting|
|Hvidovre, Denmark, 2650|
|Contact: Henrik Husted email@example.com|
|Principal Investigator: Henrik Husted|
|Vejle Sygehus, Department of orthopedic surgery||Recruiting|
|Vejle, Denmark, 7100|
|Contact: Per Kjærsgaard-Andersen firstname.lastname@example.org|
|Principal Investigator: Per Kjærsgaard-Andersen|
|Study Chair:||Henrik Kehlet, Proffessor||Rigshospitalet, Section for Surgical Pathophysiology|
|Study Director:||Oeivind Jans, M.D.||Rigshospitalet, Section for Surgical Pathophysiology|