Postoperative Orthostatic Hypotension Clinical Trial
Official title:
Efficacy of Midodrine for the Prevention of Orthostatic Hypotension During Early Mobilization After Fast-track Hip Arthroplasty - a Randomized, Placebo Controlled Trial.
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.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | September 2013 |
| Est. primary completion date | September 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Gentofte Hospital, Department of orthopaedic surgery | Hellerup | |
| Denmark | Hvidovre Hospital, Department of orthopaedic surgery | Hvidovre | |
| Denmark | Vejle Sygehus, Department of orthopedic surgery | Vejle |
| Lead Sponsor | Collaborator |
|---|---|
| Rigshospitalet, Denmark |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Haemodynamic response to mobilization 6 and 24 hours after 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) |
6 and 24 hours after end of surgery | No |
| Other | Heart rate variability | Heart rate variability measures including spectral analysis and LF/HF ratio at rest and during mobilization. | before surgery, 6- and 24 hours after surgery | No |
| Primary | Orthostatic hypotension | Orthostatic hypotension (OH) during early mobilization 6 hours after end of surgery. OH is classified according to international consensus. | 6 hours after surgery | No |
| Secondary | Orthostatic hypotension 24 hours after surgery | 24 hours after end of surgery. | No | |
| Secondary | Orthostatic Intolerance | Orthostatic intolerance is defined as subjective presyncopal symptoms (dizziness, nausea etc.) during mobilization after surgery | 6 and 24 hours after end of surgery | No |
| Secondary | Treatment side effects | The following side effects to Midodrine are evaluated: Pruritus Headache Supine hypertension Urinary retention |
6 and 24 hours after end of surgery | Yes |