Effect of Methylprednisolone on Orthostatic Intolerance and Heart Rate Variability in Hip-arthroplasty Patients
NCT ID: NCT02445898
Last Updated: 2017-01-18
Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
64 participants
INTERVENTIONAL
2015-09-30
2017-01-31
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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Methylprednisolone
Preoperative single high dose of Solu-Medrol 125 mg iv.
Methylprednisolone
Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride (placebo)
Isotonic Sodium Chloride
Preoperative single dose of isotonic Sodium Chloride
Isotonic Sodium Chloride
Placebo
Interventions
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Methylprednisolone
Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride (placebo)
Isotonic Sodium Chloride
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Undergoing total unilateral hip-arthroplasty surgery
* Speak and understand Danish
* Have given informed content
Exclusion Criteria
* General anaesthesia
* Allergy or intolerance towards Methylprednisolone
* Local or systemic infection
* Permanent systemic treatment with steroids within 30 days peroperatively
* Insulin-dependent diabetes
* Atrial fibrillation
* Neurological disease incl. Parkinsons
* Daily use of hypnotics or sedatives
* Alcohol abuse \>35 units per week
* Active treatment of ulcer within 3 months preoperatively
* Cancer disease
* Autoimmune disease incl. rheumatoid arthritis
* Pregnant or breast feeding women
* Menopause \<1 year
55 Years
80 Years
ALL
No
Sponsors
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Bispebjerg Hospital
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
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Viktoria Oline Lindberg-Larsen
MD, PhD student
Principal Investigators
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Viktoria Lindberg-Larsen, MD
Role: PRINCIPAL_INVESTIGATOR
Section for Surgical Pathophysiology, Rigshospitalet
Locations
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Copenhagen University Hospital, Bispebjerg
Copenhagen NV, , Denmark
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2015-000102-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
HK_VL_01_2015
Identifier Type: -
Identifier Source: org_study_id
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