Preoperative Single Glucocorticoid Hip Fracture Hip Fracture Surgery

NCT02317601 | Completed Phase 4 DMC

• 1 other identifier: 2014-002492-29
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium - Postoperative; Stress, Physiological

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Post operative delirium incidents measured by CAM-S

  3 days

• Patient mobility measured by Cumulated Ambulation Score (CAS)

  3 first operative days

• The degree of inflammatory response measured by biomarker in the blood (suPAR, Interleukin 6, and others)

  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).

  3 first postoperative days

• Psychiatric medications (total amount/use of psychiatric medications)

  3 post-OR days

Other Outcomes (2)

• Adverse events related to Solu-medrol

  First 3 post OR days

• Postoperative pain measured by pain score on the verbal rating scale 0-4

  First 3 post OR days

Study Arms (2)

Methylprednisolone sodium succinate

ACTIVE COMPARATOR

125 mg iv, as single dose, preoperative.

Drug: methylprednisolone sodium succinate

physiological saline

PLACEBO COMPARATOR

5 mL of Sodium-Chloride 9 mg/ml, Fresenius Kabi

Drug: placebo saline

Interventions

methylprednisolone sodium succinate DRUG

Single dose Intravenous

Also known as: Solu-medrol Product Code 52245

Methylprednisolone sodium succinate

placebo saline DRUG

physiological saline

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients undergoing surgery for hip fracture
• Informed signed consent
• Danish speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Copenhagen University Hospital Hvidovre, department of anesthesiology

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Methylprednisolone Hemisuccinate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Christopher Clemmesen, MD

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 27, 2014
• First Posted: December 16, 2014
• Study Start: December 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 18, 2016

Record last verified: 2016-07

Locations

DK (1)