Preoperative Single Glucocorticoid Hip Fracture Hip Fracture Surgery

Sponsor

Hvidovre University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02317601

Collaborator

(none)

122

Enrollment

Location

Arms

Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Delirium - Postoperative Stress, Physiological	Drug: methylprednisolone sodium succinate Drug: placebo saline	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

122 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

Preoperative Single-high Dose Glucocorticoid for Patients Undergoing Hip Fracture Surgery and the Effect on Postoperative Delirium.

Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Methylprednisolone sodium succinate 125 mg iv, as single dose, preoperative.	Drug: methylprednisolone sodium succinate Single dose Intravenous Other Names: Solu-medrol Product Code 52245
Placebo Comparator: physiological saline 5 mL of Sodium-Chloride 9 mg/ml, Fresenius Kabi	Drug: placebo saline

Arm

Intervention/Treatment

Active Comparator: Methylprednisolone sodium succinate

125 mg iv, as single dose, preoperative.

Drug: methylprednisolone sodium succinate

Single dose Intravenous

Other Names:

Solu-medrol Product Code 52245

Placebo Comparator: physiological saline

5 mL of Sodium-Chloride 9 mg/ml, Fresenius Kabi

Drug: placebo saline

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Adverse events related to Solu-medrol [First 3 post OR days]
Number of patients with adverse events
Postoperative pain measured by pain score on the verbal rating scale 0-4 [First 3 post OR days]
Measured by pain score on the verbal rating scale 0-4

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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