Preoperative Single Glucocorticoid Hip Fracture Hip Fracture Surgery

Hvidovre University Hospital122 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

122

Conditions

Delirium - Postoperative Stress, Physiological

Interventions

methylprednisolone sodium succinateDRUG

Single dose Intravenous

placebo salineDRUG

Eligibility

Sex: ALLMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Copenhagen University Hospital Hvidovre, department of anesthesiology

Hvidovre, Denmark

Outcomes

Primary Outcomes

Post operative delirium measured with Confusion Assessment Method severity measure CAM-S

Time frame: 3 first post operative days

Secondary Outcomes

Post operative delirium incidents measured by CAM-S

Incidents of delirium measured by CAM-S

Time frame: 3 days

Patient mobility measured by Cumulated Ambulation Score (CAS)

Physiotherapy

Time frame: 3 first operative days

The degree of inflammatory response measured by biomarker in the blood (suPAR, Interleukin 6, and others)

Biomarker

Time frame: 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).

Time frame: 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.

Time frame: 3 post-OR days

Postoperative infections (numbers of patients with postoperative infections)

numbers of patients with postoperative infections

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.