Preoperative Single Glucocorticoid Hip Fracture Hip Fracture Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Delirium - Postoperative, Stress, Physiological

Intervention / Treatment
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* Drug: methylprednisolone sodium succinate
* Drug: placebo saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative delirium measured with Confusion Assessment Method severity measure CAM-S | Post operative delirium measured with Confusion Assessment Method severity measure CAM-S | 3 first post operative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative delirium incidents measured by CAM-S | Incidents of delirium measured by CAM-S | 3 days | 
| Patient mobility measured by Cumulated Ambulation Score (CAS) | Physiotherapy | 3 first operative days | 
| The degree of inflammatory response measured by biomarker in the blood (suPAR, Interleukin 6, and others) | Biomarker | 4 days | 
| 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). | 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 | 
| Psychiatric medications (total amount/use of psychiatric medications) | The total amount/use of psychiatric medications for every patient during the first 3 postoperative days. | 3 post-OR days | 
| Postoperative infections (numbers of patients with postoperative infections) | numbers of patients with postoperative infections | 21 days | 
| Length of stay in hospital | participants will be followed for the duration of hospital stay, an expected average of 3 weeks | 21 days |