Does Steroids have an effect on Delirium amoung older Adults undergoing surgery for Hip Fracture?

Phase 1

• Conditions: Postoperative Delirium; MedDRA version: 17.0Level: PTClassification code 10012218Term: DeliriumSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 17.0Level: LLTClassification code 10012220Term: Delirium due to a general medical conditionSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 17.0Level: LLTClassification code 10000702Term: Acute deliriumSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2014-002492-29-DK
• Lead Sponsor: Department of anaesthesia and intensive care, Hvidovre Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-20
• Last Update Posted: 27 June 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Undergoing surgery for hip fracture
Age minimum 65 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

Allergies too glucocorticoider
More then one fracture
If the patientes have insulin dependent diabetes
If the patient already treated with glucocorticoider

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective is to investigate the effect of perioperative glucocorticoids on postoperative delirium. The hypothesis is that it can reduce incidents and severity of postoperative delirium amoung elderly patientes undergoing surgery for Hip fracture. ;Secondary Objective: Secondary objectives are to investigate other positive effect of perioperative single-dose glucocorticoids.;Primary end point(s): Incidens and severity of delirium measured with the CAM ( The Confusion Assessment Method);Timepoint(s) of evaluation of this end point: The first three days of admission

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Length of stay in hospital<br>Fatigue postoperative<br>Postoperative infections<br>;Timepoint(s) of evaluation of this end point: The patients admission