Efficacy of Midodrine for the Prevention of Orthostatic Hypotension During Early Mobilization After Fast-track Hip Arthroplasty
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|