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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02445898
• Date of registration: 13/05/2015
• Prospective Registration: Yes
• Primary sponsor: Rigshospitalet, Denmark
• Public title: Effect of Methylprednisolone on Orthostatic Intolerance and Heart Rate Variability in Hip-arthroplasty Patients
• Scientific title: Effect of Preoperative Intravenous High Dose Methylprednisolone on Orthostatic Intolerance and Heart Rate Variability in Patients Scheduled for Total Hip-arthroplasty
• Date of first enrolment: September 2015
• Target sample size: 64
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02445898
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

Denmark

Contacts

• Name: Viktoria Lindberg-Larsen, MD
• Affiliation: Section for Surgical Pathophysiology, Rigshospitalet

Key inclusion & exclusion 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



Age minimum: 55 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Osteoarthrosis

Intervention(s)

Drug: Methylprednisolone

Drug: Isotonic Sodium Chloride

Primary Outcome(s)

Difference in incidence of orthostatic intolerance from baseline to 6 hours after surgery [Time Frame: 6 hours after surgery]

Secondary Outcome(s)

Change in stroke volume and cardiac output from baseline to 24 hours after surgery [Time Frame: 24 hours after surgery]

Change in pain intensity from baseline to 24 hours after surgery [Time Frame: 24 hours after surgery]

Change in systemic vascular resistance from baseline to 24 hours after surgery [Time Frame: 24 hours after surgery]

Change in concentration of C-reactive protein from baseline to 48 hours after surgery [Time Frame: 48 hours after surgery]

Change in heart rate variability from baseline to 24 hours after surgery [Time Frame: 24 hours after surgery]

Change in non-invasive blood pressure from baseline to 24 hours after surgery [Time Frame: 24 hours after surgery]

Change in concentration of plasma-hemoglobin from baseline to 48 hours after surgery [Time Frame: 48 hours after surgery]

Difference in incidence of orthostatic intolerance from baseline to 24 hours after surgery [Time Frame: 24 hours after surgery]

Secondary ID(s)

2015-000102-19

HK_VL_01_2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bispebjerg Hospital