Clinical trial NCT02317601: Preoperative Single Glucocorticoid Hip Fracture Hip Fracture Surgery
Official title: Preoperative Single-high Dose Glucocorticoid for Patients Undergoing Hip Fracture Surgery and the Effect on Postoperative Delirium.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Delirium - Postoperative
Stress, Physiological
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2014-12-16
Enrollment: 122
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post operative delirium measured with Confusion Assessment Method severity measure CAM-S
timeFrame: 3 first post operative days
Secondary outcomes:
measure: Post operative delirium incidents measured by CAM-S
timeFrame: 3 days
measure: Patient mobility measured by Cumulated Ambulation Score (CAS)
timeFrame: 3 first operative days
measure: The degree of inflammatory response measured by biomarker in the blood (suPAR, Interleukin 6, and others)
timeFrame: 4 days
measure: 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).
timeFrame: 3 first postoperative days
measure: Psychiatric medications (total amount/use of psychiatric medications)
timeFrame: 3 post-OR days
measure: Postoperative infections (numbers of patients with postoperative infections)
timeFrame: 21 days
measure: Length of stay in hospital
timeFrame: 21 days
Other outcomes:
measure: Adverse events related to Solu-medrol
timeFrame: First 3 post OR days
measure: Postoperative pain measured by pain score on the verbal rating scale 0-4
timeFrame: First 3 post OR days
Locations:
city: Hvidovre
country: Denmark
facility: Copenhagen University Hospital Hvidovre, department of anesthesiology
Study officials:
affiliation: Hvidovre University Hospital
name: Christopher Clemmesen, MD
role: PRINCIPAL_INVESTIGATOR
References: