Preoperative Single Glucocorticoid Hip Fracture Hip Fracture Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Stress, Physiological; Delirium - Postoperative
• Intervention / Treatment: Drug: methylprednisolone sodium succinate; Drug: placebo saline

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.

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Copenhagen University Hospital Hvidovre, department of anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	First 3 post OR days

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Investigators: Principal Investigator: Christopher Clemmesen, MD, Hvidovre University Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: November 27, 2014
• First Submitted That Met QC Criteria: December 15, 2014
• First Posted (Estimate): December 16, 2014

Study Record Updates

• Last Update Posted (Estimate): July 18, 2016
• Last Update Submitted That Met QC Criteria: July 15, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Leg Injuries; Femoral Fractures; Hip Injuries; Delirium; Hip Fractures; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: 2014-002492-29 (EudraCT Number)