Effect of Methylprednisolone on Glucose Homeostasis in Patients Undergoing Total Hip- and Knee-arthroplasty
NCT ID: NCT02332603
Last Updated: 2017-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
134 participants
INTERVENTIONAL
2015-01-31
2017-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will receive placebo.
The investigators hypothesize that the glucose homeostasis remains equally stable in the group receiving Methylprednisolone as in the group receiving placebo.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Methylprednisolone on Endothelial Function in Patients Undergoing Total Knee-arthroplasty
NCT02332629
Effect of Methylprednisolone on Quadriceps Muscle Function in Patients Undergoing Total Knee-arthroplasty
NCT02319343
Effect of Methylprednisolone on Complement Activation in Patients Undergoing Total Knee-arthroplasty
NCT02332616
Effects of Methylprednisolone After Total Knee Arthroplasty
NCT00968578
Preoperative Intraarticular Injection of Methylprednisolone in Patients Scheduled for Total Knee-arthroplasty
NCT02253966
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Glucocorticoid might change the glucose metabolism as it induces insulin-resistance. Glucocorticoids are known to reduce the insulin-mediated glucose uptake by reducing the muscle glycogen synthase activity.
The effect of a single high dose of glucocorticoid is poorly described in the literature, and therefore calls for further investigation.
This study is embedded in a primary study registrated as: NCT02319343
For further details please view the EudraCT registration:
EudraCT nr.: 2014-003395-23
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Isotonic Sodium Chloride
Preoperative single dose of isotonic Sodium Chloride
Isotonic Sodium Chloride
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Methylprednisolone
Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride
Isotonic Sodium Chloride
Placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Undergoing total unilateral hip- or knee arthroplasty surgery
* Speak and understand Danish
* Have given informed consent
Exclusion Criteria
* General anaesthesia
* Allergy or intolerance towards Methylprednisolone
* Local or systemic infection
* Permanent systemic treatment with steroids within 30 days preoperatively
* Insulin-dependent diabetes
* 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
Meet the organizations funding or collaborating on the study and learn about their roles.
Bispebjerg Hospital
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Viktoria Oline Lindberg-Larsen
MD, research assistant
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Viktoria Lindberg-Larsen, MD
Role: PRINCIPAL_INVESTIGATOR
Section for Surgical Pathophysiology, Rigshospitalet
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bispebjerg Hospital
Copenhagen NV, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Khan SK, Malviya A, Muller SD, Carluke I, Partington PF, Emmerson KP, Reed MR. Reduced short-term complications and mortality following Enhanced Recovery primary hip and knee arthroplasty: results from 6,000 consecutive procedures. Acta Orthop. 2014 Feb;85(1):26-31. doi: 10.3109/17453674.2013.874925. Epub 2013 Dec 20.
Malviya A, Martin K, Harper I, Muller SD, Emmerson KP, Partington PF, Reed MR. Enhanced recovery program for hip and knee replacement reduces death rate. Acta Orthop. 2011 Oct;82(5):577-81. doi: 10.3109/17453674.2011.618911. Epub 2011 Sep 6.
Abdelmalak BB, Bonilla AM, Yang D, Chowdary HT, Gottlieb A, Lyden SP, Sessler DI. The hyperglycemic response to major noncardiac surgery and the added effect of steroid administration in patients with and without diabetes. Anesth Analg. 2013 May;116(5):1116-1122. doi: 10.1213/ANE.0b013e318288416d. Epub 2013 Apr 4.
Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear T, Vender JS, Gray J, Landry E. The effect of single low-dose dexamethasone on blood glucose concentrations in the perioperative period: a randomized, placebo-controlled investigation in gynecologic surgical patients. Anesth Analg. 2014 Jun;118(6):1204-12. doi: 10.1213/ANE.0b013e3182a53981.
de la Motte L, Kehlet H, Vogt K, Nielsen CH, Groenvall JB, Nielsen HB, Andersen A, Schroeder TV, Lonn L. Preoperative methylprednisolone enhances recovery after endovascular aortic repair: a randomized, double-blind, placebo-controlled clinical trial. Ann Surg. 2014 Sep;260(3):540-8; discussion 548-9. doi: 10.1097/SLA.0000000000000895.
Dieleman JM, Nierich AP, Rosseel PM, van der Maaten JM, Hofland J, Diephuis JC, Schepp RM, Boer C, Moons KG, van Herwerden LA, Tijssen JG, Numan SC, Kalkman CJ, van Dijk D; Dexamethasone for Cardiac Surgery (DECS) Study Group. Intraoperative high-dose dexamethasone for cardiac surgery: a randomized controlled trial. JAMA. 2012 Nov 7;308(17):1761-7. doi: 10.1001/jama.2012.14144.
Lindberg-Larsen V, Kehlet H, Bagger J, Madsbad S. Preoperative High-Dose Methylprednisolone and Glycemic Control Early After Total Hip and Knee Arthroplasty: A Randomized, Double-Blind, Placebo-Controlled Trial. Anesth Analg. 2018 Oct;127(4):906-913. doi: 10.1213/ANE.0000000000003591.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HK_VL_08_2014c
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.