Delirium - Postoperative, Stress, Physiological
Conditions
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.
Interventions
DRUGmethylprednisolone sodium succinate
Single dose Intravenous
DRUGplacebo saline
Sponsors
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Denmark
Outcome results
None listed