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Preoperative Single Glucocorticoid Hip Fracture Hip Fracture Surgery

H

Hvidovre University Hospital

Status and phase

Completed
Phase 4

Conditions

Delirium - Postoperative
Stress, Physiological

Treatments

Drug: placebo saline
Drug: methylprednisolone sodium succinate

Study type

Interventional

Funder types

Other

Identifiers

NCT02317601
2014-002492-29 (EudraCT Number)

Details and patient eligibility

About

The Study is a double-blinded, randomized, placebo-controlled trials. The Objective is to investigate the effect of single-high-dose glucocorticoid on surgical stress response and postoperative delirium among Elderly hip Fracture Patients undergoing surgery.

Full description

Patients with Hip Fracture are exposed for two traumas that can trigger a stress response. The first is the fall that causes the Fracture. The second is the surgery. In this study the intervention is dispensed early in the disease course - as soon as the Fracture has been diagnosed and booked for surgery.

Enrollment

122 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients undergoing surgery for hip fracture
  • Informed signed consent
  • Danish speaking

Exclusion criteria

  • Allergies towards contents of Solu-Medrol
  • Insulin dependent diabetes
  • Glaucoma
  • In treatment for cancer disease
  • Positive HIV, Hepatitis b or C status
  • Lack of informed consent (eq. Severe dementia, coma, and others)
  • Current treatment with systemic glucocorticoids (pr.os or intravenous) Immunoinflammatory disease (Except topical treated skin disease and respiratory disease)
  • Current Immunosuppressive treatment
  • Unable to participate in CAM-S measurement
  • Peptic ulcera

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

122 participants in 2 patient groups, including a placebo group

Methylprednisolone sodium succinate
Active Comparator group
Description:
125 mg iv, as single dose, preoperative.
Treatment:
Drug: methylprednisolone sodium succinate
physiological saline
Placebo Comparator group
Description:
5 mL of Sodium-Chloride 9 mg/ml, Fresenius Kabi
Treatment:
Drug: placebo saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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