Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002572-13 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midodrine | Experimental | Midodrine Hydrochloride (5mg) administered as capsule 5 and 23 hours after end of surgery. |
|
| Placebo | Placebo Comparator | Placebo administered as capsule 5- and 23 hours after end of surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midodrine | Drug | Midodrine 5mg as capsule, administered twice (5 and 23 hours after end of surgery). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Orthostatic hypotension 24 hours after surgery | 24 hours after end of surgery. | |
| Orthostatic Intolerance | Orthostatic intolerance is defined as subjective presyncopal symptoms (dizziness, nausea etc.) during mobilization after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Haemodynamic response to mobilization 6 and 24 hours after surgery | Haemodynamic response to mobilization (supine, sitting and standing):
| 6 and 24 hours after end of surgery |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Henrik Kehlet, Proffessor | Rigshospitalet, Section for Surgical Pathophysiology | Study Chair |
| Oeivind Jans, M.D. | Rigshospitalet, Section for Surgical Pathophysiology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gentofte Hospital, Department of orthopaedic surgery | Hellerup | 2900 | Denmark | |||
| Hvidovre Hospital, Department of orthopaedic surgery |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo capsule to mimic midodrine |
|
| 6 and 24 hours after end of surgery |
| Treatment side effects | The following side effects to Midodrine are evaluated:
| 6 and 24 hours after end of surgery |
| 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 |
| Hvidovre |
| 2650 |
| Denmark |
| Vejle Sygehus, Department of orthopedic surgery | Vejle | 7100 | Denmark |
| ID | Term |
|---|---|
| D008879 | Midodrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
Not provided
Not provided