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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002492-29 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylprednisolone sodium succinate | Active Comparator | 125 mg iv, as single dose, preoperative. |
|
| physiological saline | Placebo Comparator | 5 mL of Sodium-Chloride 9 mg/ml, Fresenius Kabi |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylprednisolone sodium succinate | Drug | Single dose Intravenous |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events related to Solu-medrol | Number of patients with adverse events | First 3 post OR days |
| Postoperative pain measured by pain score on the verbal rating scale 0-4 | Measured by pain score on the verbal rating scale 0-4 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Clemmesen, MD | Hvidovre University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital Hvidovre, department of anesthesiology | Hvidovre | 2650 | Denmark |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D008776 | Methylprednisolone Hemisuccinate |
| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
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| placebo saline | Drug |
|
| 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 |
| First 3 post OR days |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D011278 |
| Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |