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Effect of Methylprednisolone on Orthostatic Intolerance and Heart Rate Variability in Hip-arthroplasty Patients

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ClinicalTrials.gov Identifier: NCT02445898
Recruitment Status : Completed
First Posted : May 15, 2015
Last Update Posted : January 18, 2017
Sponsor:
Collaborator:
Bispebjerg Hospital
Information provided by (Responsible Party):
Viktoria Oline Lindberg-Larsen, Rigshospitalet, Denmark

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Osteoarthrosis Drug: Methylprednisolone Drug: Isotonic Sodium Chloride Phase 2 Phase 3

Detailed Description:

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Effect of Preoperative Intravenous High Dose Methylprednisolone on Orthostatic Intolerance and Heart Rate Variability in Patients Scheduled for Total Hip-arthroplasty
Study Start Date : September 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017


Arm Intervention/treatment
Active Comparator: Methylprednisolone
Preoperative single high dose of Solu-Medrol 125 mg iv.
Drug: Methylprednisolone
Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride (placebo)
Other Name: Solu-Medrol

Placebo Comparator: Isotonic Sodium Chloride
Preoperative single dose of isotonic Sodium Chloride
Drug: Isotonic Sodium Chloride
Placebo




Primary Outcome Measures :
  1. Difference in incidence of orthostatic intolerance from baseline to 6 hours after surgery [ Time Frame: 6 hours after surgery ]

Secondary Outcome Measures :
  1. Difference in incidence of orthostatic intolerance from baseline to 24 hours after surgery [ Time Frame: 24 hours after surgery ]
  2. Change in non-invasive blood pressure from baseline to 24 hours after surgery [ Time Frame: 24 hours after surgery ]
  3. Change in heart rate variability from baseline to 24 hours after surgery [ Time Frame: 24 hours after surgery ]
  4. Change in stroke volume and cardiac output from baseline to 24 hours after surgery [ Time Frame: 24 hours after surgery ]
  5. Change in systemic vascular resistance from baseline to 24 hours after surgery [ Time Frame: 24 hours after surgery ]
  6. Change in pain intensity from baseline to 24 hours after surgery [ Time Frame: 24 hours after surgery ]
  7. Change in concentration of plasma-hemoglobin from baseline to 48 hours after surgery [ Time Frame: 48 hours after surgery ]
  8. Change in concentration of C-reactive protein from baseline to 48 hours after surgery [ Time Frame: 48 hours after surgery ]


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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Osteoarthrosis
  • Undergoing total unilateral hip-arthroplasty surgery
  • Speak and understand Danish
  • Have given informed content

Exclusion Criteria:

  • Revision or bilateral hip-arthroplasty surgery
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02445898


Locations
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Denmark
Copenhagen University Hospital, Bispebjerg
Copenhagen NV, Denmark, 2400
Sponsors and Collaborators
Rigshospitalet, Denmark
Bispebjerg Hospital
Investigators
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Principal Investigator: Viktoria Lindberg-Larsen, MD Section for Surgical Pathophysiology, Rigshospitalet

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Viktoria Oline Lindberg-Larsen, MD, PhD student, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02445898     History of Changes
Other Study ID Numbers: HK_VL_01_2015
2015-000102-19 ( EudraCT Number )
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Keywords provided by Viktoria Oline Lindberg-Larsen, Rigshospitalet, Denmark:
Glucocorticoid
Orthostatic Intolerance
Heart Rate Variability
Hip arthroplasty, total
Additional relevant MeSH terms:
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Osteoarthritis
Orthostatic Intolerance
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal