Preoperative Single Glucocorticoid Hip Fracture Hip Fracture Surgery

Stress, Physiological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02317601
• Other study ID #: 2014-002492-29
• Secondary ID: 2014-002492-29
• Status: Completed
• Phase: Phase 4
• First received: November 27, 2014
• Last updated: July 15, 2016
• Start date: December 2014
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Delirium
• Delirium - Postoperative
• Hip Fractures
• Stress, Physiological

Intervention

Drug:
• methylprednisolone sodium succinate
Single dose Intravenous
• placebo saline

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital Hvidovre, department of anesthesiology	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events related to Solu-medrol	Number of patients with adverse events	First 3 post OR days	Yes
Other	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	No
Primary	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	Yes
Secondary	Post operative delirium incidents measured by CAM-S	Incidents of delirium measured by CAM-S	3 days	Yes
Secondary	Patient mobility measured by Cumulated Ambulation Score (CAS)	Physiotherapy	3 first operative days	No
Secondary	The degree of inflammatory response measured by biomarker in the blood (suPAR, Interleukin 6, and others)	Biomarker	4 days	No
Secondary	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	No
Secondary	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	No
Secondary	Postoperative infections (numbers of patients with postoperative infections)	numbers of patients with postoperative infections	21 days	No
Secondary	Length of stay in hospital	participants will be followed for the duration of hospital stay, an expected average of 3 weeks	21 days	No