Effect og highdose glucocorticoid on postural low blood pressure, sleeping pattern, blood sugar balance and immune system signaling in patients scheduled for total hip replacement

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]; Hip joint arthrosis; MedDRA version: 18.0Level: LLTClassification code 10003416Term: ArthrosisSystem Organ Class: 100000004859

• Registration Number: EUCTR2015-000102-19-DK
• Lead Sponsor: Section for Surgical Pathophysiology, Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-29
• Last Update Posted: 16 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Age 55-80 years
- Osteoarthrosis scheduled for primary unilateral hip-arthroplasty
- Speak and understand Danish
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44

Exclusion Criteria

- Allergy towards methylprednisolone
- Scheduled for hip revision or bilateral surgery
- Infection (local or systemic)
- General anaesthesia
- Current use of steroids
- Insulin treated diabetes
- Atrial fibrillation
- Neurological disease incl. Parkinsons
- Daily use of hypnotics and sedativas
- Treatment for ulcus <3 months preoperatively
- Cancer disease
- Alcohol abuse (>35 units per week)
- Autoimmune disease
- Pregnant or breast feeding women
- Menopause <1 year

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified