Efficacy of Midodrine for the Prevention of Orthostatic Hypotension During Early Mobilization After Fast-track Hip Arthroplasty
|ClinicalTrials.gov Identifier: NCT01707953|
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : January 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Orthostatic Hypotension Postoperative Orthostatic Intolerance||Drug: Midodrine Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 :||October 2012|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
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
- Orthostatic hypotension [ Time Frame: 6 hours after surgery ]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. ]
- Orthostatic Intolerance [ Time Frame: 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 [ Time Frame: 6 and 24 hours after end of surgery ]
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 ]
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 ]Heart rate variability measures including spectral analysis and LF/HF ratio at rest and during mobilization.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707953
|Gentofte Hospital, Department of orthopaedic surgery|
|Hellerup, Denmark, 2900|
|Hvidovre Hospital, Department of orthopaedic surgery|
|Hvidovre, Denmark, 2650|
|Vejle Sygehus, Department of orthopedic surgery|
|Vejle, Denmark, 7100|
|Study Chair:||Henrik Kehlet, Proffessor||Rigshospitalet, Section for Surgical Pathophysiology|
|Study Director:||Oeivind Jans, M.D.||Rigshospitalet, Section for Surgical Pathophysiology|