Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000102-19 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bispebjerg Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study evaluates the pathophysiological effects of a single dose Methylprednisolone administered prior to total hip-arthroplasty (THA) surgery. The investigators examine the effect on orthostatic intolerance, orthostatic hypotension and heart rate variability (HRV) to evaluate the efficacy of Methylprednisolone regarding blood pressure regulation and autonomic responses after THA.
Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will receive placebo.
The investigators hypothesize that the group receiving Methylprednisolone will be less orthostatic intolerant, experience less orthostatic hypotension and have an improved autonomic response compared to the placebo-group, early after THA.
The anti-inflammatory effects of glucocorticoids are well known. The beneficial effects in postoperative pain, postoperative nausea and vomiting are well-documented.
Hip-arthroplasty surgery and the inflammatory stress response in general affect the potential of recovery. Early postoperative orthostatic intolerance is common in patients undergoing THA with an incidence of 40%. The mechanism is thought related to an impaired autonomic regulation caused by surgery-induced inflammation. The effect of glucocorticoids on orthostatic intolerance, orthostatic hypotension and HRV after hip-arthroplasty surgery is unknown and calls for further investigation.
The study is to be considered as exploratory. The primary analysis of the primary outcome measure is a comparison of the incidence of orthostatic intolerance from baseline to 6 hours postoperatively between the two groups.
For calculation of sample size the difference in incidence between groups (40% versus 10%) from baseline (before surgery) to 6 hours after THA-surgery, a risk of type I errors 5% and a risk of type II errors 20% (80% power) were used.
The primary analysis is carried out on all included patients (intention-to-treat) with baseline values as covariate. Secondary exploratory per-protocol analysis might be performed. Missing outcomes will be analysed using multiple imputation due to expected strong time trends.
The secondary outcomes measures; Non-invasive blood pressure, systemic vascular resistance, cardiac output, HRV, plasma-hemoglobin, C-reactive protein.
For further details please also view the European Clinical Trials Database (EudraCT) registration:
EudraCT nr.: 2015-000102-19
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylprednisolone | Active Comparator | Preoperative single high dose of Solu-Medrol 125 mg iv. |
|
| Isotonic Sodium Chloride | Placebo Comparator | Preoperative single dose of isotonic Sodium Chloride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone | Drug | Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride (placebo) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in incidence of orthostatic intolerance from baseline to 6 hours after surgery | 6 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in incidence of orthostatic intolerance from baseline to 24 hours after surgery | 24 hours after surgery | |
| Change in non-invasive blood pressure from baseline to 24 hours after surgery | 24 hours after surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Viktoria Lindberg-Larsen, MD | Section for Surgical Pathophysiology, Rigshospitalet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital, Bispebjerg | Copenhagen NV | 2400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23205862 | Background | Husted H. Fast-track hip and knee arthroplasty: clinical and organizational aspects. Acta Orthop Suppl. 2012 Oct;83(346):1-39. doi: 10.3109/17453674.2012.700593. | |
| 23663938 | Background | Kehlet H. Fast-track hip and knee arthroplasty. Lancet. 2013 May 11;381(9878):1600-2. doi: 10.1016/S0140-6736(13)61003-X. No abstract available. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D054971 | Orthostatic Intolerance |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D008776 | Methylprednisolone Hemisuccinate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Isotonic Sodium Chloride | Drug | Placebo |
|
| Change in heart rate variability from baseline to 24 hours after surgery | 24 hours after surgery |
| Change in stroke volume and cardiac output from baseline to 24 hours after surgery | 24 hours after surgery |
| Change in systemic vascular resistance from baseline to 24 hours after surgery | 24 hours after surgery |
| Change in pain intensity from baseline to 24 hours after surgery | 24 hours after surgery |
| Change in concentration of plasma-hemoglobin from baseline to 48 hours after surgery | 48 hours after surgery |
| Change in concentration of C-reactive protein from baseline to 48 hours after surgery | 48 hours after surgery |
| 15939833 | Background | Grubb BP. Neurocardiogenic syncope and related disorders of orthostatic intolerance. Circulation. 2005 Jun 7;111(22):2997-3006. doi: 10.1161/CIRCULATIONAHA.104.482018. No abstract available. |
| 23756453 | Background | Bundgaard-Nielsen M, Jans O, Muller RG, Korshin A, Ruhnau B, Bie P, Secher NH, Kehlet H. Does goal-directed fluid therapy affect postoperative orthostatic intolerance?: A randomized trial. Anesthesiology. 2013 Oct;119(4):813-23. doi: 10.1097/ALN.0b013e31829ce4ea. |
| 19398452 | Background | Bundgaard-Nielsen M, Jorgensen CC, Jorgensen TB, Ruhnau B, Secher NH, Kehlet H. Orthostatic intolerance and the cardiovascular response to early postoperative mobilization. Br J Anaesth. 2009 Jun;102(6):756-62. doi: 10.1093/bja/aep083. Epub 2009 Apr 27. |
| 22174345 | Result | Jans O, Bundgaard-Nielsen M, Solgaard S, Johansson PI, Kehlet H. Orthostatic intolerance during early mobilization after fast-track hip arthroplasty. Br J Anaesth. 2012 Mar;108(3):436-43. doi: 10.1093/bja/aer403. Epub 2011 Dec 15. |
| 29573263 | Derived | Lindberg-Larsen V, Petersen PB, Jans O, Beck T, Kehlet H. Effect of pre-operative methylprednisolone on orthostatic hypotension during early mobilization after total hip arthroplasty. Acta Anaesthesiol Scand. 2018 Aug;62(7):882-892. doi: 10.1111/aas.13108. Epub 2018 Mar 24. |
| D054969 |
| Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |