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Completed

NCT Number: NCT02317601

Preoperative Single Glucocorticoid Hip Fracture Hip Fracture Surgery

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.

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Key information

Conditions

Delirium - Postoperative Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Stress, Physiological

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Copenhagen University Hospital Hvidovre, department of anesthesiology

Hvidovre, 2650, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylprednisolone Sodium Succinate

Drug

Single dose Intravenous

Other names: Solu-medrol Product Code 52245

Placebo saline

Drug

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 16, 2014
Registry last updated
Jul 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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