Preoperative Single Glucocorticoid Hip Fracture Hip Fracture Surgery

Phase 4

Completed

• Conditions: Delirium - Postoperative; Stress, Physiological
• Interventions: Drug: placebo saline; Drug: methylprednisolone sodium succinate

• Registration Number: NCT02317601
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-11-27
• Study Start: 2014-12
• Study First Submitted QC: 2014-12-15
• Study First Posted: 2014-12-16
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-15
• Last Update Posted: 2016-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
physiological saline	placebo saline	5 mL of Sodium-Chloride 9 mg/ml, Fresenius Kabi
Methylprednisolone sodium succinate	methylprednisolone sodium succinate	125 mg iv, as single dose, preoperative.

Primary Outcome Measures

Name	Time	Method
Post operative delirium measured with Confusion Assessment Method severity measure CAM-S	3 first post operative days	Post operative delirium measured with Confusion Assessment Method severity measure CAM-S

Secondary Outcome Measures

Name	Time	Method
Post operative delirium incidents measured by CAM-S	3 days	Incidents of delirium measured by CAM-S
Patient mobility measured by Cumulated Ambulation Score (CAS)	3 first operative days	Physiotherapy
The degree of inflammatory response measured by biomarker in the blood (suPAR, Interleukin 6, and others)	4 days	Biomarker
Post operative Fatigue measured with a patient fatigue self-assessment 0-4. (Verbal rating scale) 0=no fatigue, 1=mild, 2 = moderate, 3 = severe, 4 = excruciating (in bed because of fatigue).	3 first postoperative days	Measured with a patient fatigue self-assessment 0-4. (Verbal rating scale) 0=no fatigue, 1=mild, 2 = moderate, 3 = severe, 4 = excruciating (in bed because of fatigue).
Psychiatric medications (total amount/use of psychiatric medications)	3 post-OR days	The total amount/use of psychiatric medications for every patient during the first 3 postoperative days.
Postoperative infections (numbers of patients with postoperative infections)	21 days	numbers of patients with postoperative infections
Length of stay in hospital	21 days	participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Trial Locations

Locations (1)

Copenhagen University Hospital Hvidovre, department of anesthesiology; 🇩🇰 Hvidovre, Denmark