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Preoperative Single Glucocorticoid Hip Fracture Hip Fracture Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02317601
Recruitment Status : Completed
First Posted : December 16, 2014
Last Update Posted : July 18, 2016
Sponsor:
Information provided by (Responsible Party):
Christopher Clemmesen, Hvidovre University Hospital

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.

Condition or disease Intervention/treatment Phase
Delirium - Postoperative Stress, Physiological Drug: methylprednisolone sodium succinate Drug: placebo saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Preoperative Single-high Dose Glucocorticoid for Patients Undergoing Hip Fracture Surgery and the Effect on Postoperative Delirium.
Study Start Date : December 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016


Arm Intervention/treatment
Active Comparator: Methylprednisolone sodium succinate
125 mg iv, as single dose, preoperative.
Drug: methylprednisolone sodium succinate
Single dose Intravenous
Other Name: Solu-medrol Product Code 52245

Placebo Comparator: physiological saline
5 mL of Sodium-Chloride 9 mg/ml, Fresenius Kabi
Drug: placebo saline



Primary Outcome Measures :
  1. Post operative delirium measured with Confusion Assessment Method severity measure CAM-S [ Time Frame: 3 first post operative days ]
    Post operative delirium measured with Confusion Assessment Method severity measure CAM-S


Secondary Outcome Measures :
  1. Post operative delirium incidents measured by CAM-S [ Time Frame: 3 days ]
    Incidents of delirium measured by CAM-S

  2. Patient mobility measured by Cumulated Ambulation Score (CAS) [ Time Frame: 3 first operative days ]
    Physiotherapy

  3. The degree of inflammatory response measured by biomarker in the blood (suPAR, Interleukin 6, and others) [ Time Frame: 4 days ]
    Biomarker

  4. 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). [ Time Frame: 3 first postoperative days ]
    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).

  5. Psychiatric medications (total amount/use of psychiatric medications) [ Time Frame: 3 post-OR days ]
    The total amount/use of psychiatric medications for every patient during the first 3 postoperative days.

  6. Postoperative infections (numbers of patients with postoperative infections) [ Time Frame: 21 days ]
    numbers of patients with postoperative infections

  7. Length of stay in hospital [ Time Frame: 21 days ]
    participants will be followed for the duration of hospital stay, an expected average of 3 weeks


Other Outcome Measures:
  1. Adverse events related to Solu-medrol [ Time Frame: First 3 post OR days ]
    Number of patients with adverse events

  2. Postoperative pain measured by pain score on the verbal rating scale 0-4 [ Time Frame: First 3 post OR days ]
    Measured by pain score on the verbal rating scale 0-4



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02317601


Locations
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Denmark
Copenhagen University Hospital Hvidovre, department of anesthesiology
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
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Principal Investigator: Christopher Clemmesen, MD Hvidovre University Hospital

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Responsible Party: Christopher Clemmesen, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02317601    
Other Study ID Numbers: 2014-002492-29
2014-002492-29 ( EudraCT Number )
First Posted: December 16, 2014    Key Record Dates
Last Update Posted: July 18, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Delirium
Hip Fractures
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Glucocorticoids
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists