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

The effect of Single-Dose Glucocorticoid on Postoperative delirium among Elderly Hip Fracture Patientes: A Randomized Placebo Controlled Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002492-29-DK

Enrollment

120

Registered

2014-06-20

Start date

2014-10-10

Completion date

Unknown

Last updated

2016-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Delirium MedDRA version: 17.0 Level: PT Classification code 10012218 Term: Delirium System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 17.0 Level: LLT Classification code 10012220 Term: Delirium due to a general medical condition System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 17.0 Level: LLT Classification code 10000702 Term: Acute delirium System Organ Class: 10037175 - Psychiatric disorders

Interventions

Trade Name: Solu-Medrol Product Name: solu medrol Product Code: 52245 Pharmaceutical Form: Concentrate and solvent for solution for injection INN or Proposed INN: Methylprednisolon Other descriptive n

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): Length of stay in hospital Fatigue postoperative Postoperative infections ;Timepoint(s) of evaluation of this end point: The patients admission	—

Countries

Denmark

Contacts

Public ContactNicolai Bang Foss

Department of anaesthesia and intensive care, Hvidovre Hospital

nicolai.bang.foss@hvh.regionh.dk+4538622518

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026