Back to resultsPreoperative Single Glucocorticoid Hip Fracture Hip Fracture Surgery
Primary Purpose
Delirium - Postoperative, Stress, Physiological
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
methylprednisolone sodium succinate
placebo saline
Sponsored by
About this trial
This is an interventional prevention trial for Delirium - Postoperative
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
Sites / Locations
- Copenhagen University Hospital Hvidovre, department of anesthesiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Methylprednisolone sodium succinate
physiological saline
Arm Description
125 mg iv, as single dose, preoperative.
5 mL of Sodium-Chloride 9 mg/ml, Fresenius Kabi
Outcomes
Primary Outcome Measures
Post operative delirium measured with Confusion Assessment Method severity measure CAM-S
Post operative delirium measured with Confusion Assessment Method severity measure CAM-S
Secondary Outcome Measures
Post operative delirium incidents measured by CAM-S
Incidents of delirium measured by CAM-S
Patient mobility measured by Cumulated Ambulation Score (CAS)
Physiotherapy
The degree of inflammatory response measured by biomarker in the blood (suPAR, Interleukin 6, and others)
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).
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).
Psychiatric medications (total amount/use of psychiatric medications)
The total amount/use of psychiatric medications for every patient during the first 3 postoperative days.
Postoperative infections (numbers of patients with postoperative infections)
numbers of patients with postoperative infections
Length of stay in hospital
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Full Information
NCT ID
NCT02317601
First Posted
November 27, 2014
Last Updated
July 15, 2016
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02317601
Brief Title
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
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium - Postoperative, Stress, Physiological
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methylprednisolone sodium succinate
Arm Type
Active Comparator
Arm Description
125 mg iv, as single dose, preoperative.
Arm Title
physiological saline
Arm Type
Placebo Comparator
Arm Description
5 mL of Sodium-Chloride 9 mg/ml, Fresenius Kabi
Intervention Type
Drug
Intervention Name(s)
methylprednisolone sodium succinate
Other Intervention Name(s)
Solu-medrol Product Code 52245
Intervention Description
Single dose Intravenous
Intervention Type
Drug
Intervention Name(s)
placebo saline
Primary Outcome Measure Information:
Title
Post operative delirium measured with Confusion Assessment Method severity measure CAM-S
Description
Post operative delirium measured with Confusion Assessment Method severity measure CAM-S
Time Frame
3 first post operative days
Secondary Outcome Measure Information:
Title
Post operative delirium incidents measured by CAM-S
Description
Incidents of delirium measured by CAM-S
Time Frame
3 days
Title
Patient mobility measured by Cumulated Ambulation Score (CAS)
Description
Physiotherapy
Time Frame
3 first operative days
Title
The degree of inflammatory response measured by biomarker in the blood (suPAR, Interleukin 6, and others)
Description
Biomarker
Time Frame
4 days
Title
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).
Description
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
Title
Psychiatric medications (total amount/use of psychiatric medications)
Description
The total amount/use of psychiatric medications for every patient during the first 3 postoperative days.
Time Frame
3 post-OR days
Title
Postoperative infections (numbers of patients with postoperative infections)
Description
numbers of patients with postoperative infections
Time Frame
21 days
Title
Length of stay in hospital
Description
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Time Frame
21 days
Other Pre-specified Outcome Measures:
Title
Adverse events related to Solu-medrol
Description
Number of patients with adverse events
Time Frame
First 3 post OR days
Title
Postoperative pain measured by pain score on the verbal rating scale 0-4
Description
Measured by pain score on the verbal rating scale 0-4
Time Frame
First 3 post OR days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Clemmesen, MD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen University Hospital Hvidovre, department of anesthesiology
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Preoperative Single Glucocorticoid Hip Fracture Hip Fracture Surgery
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