The DETEcT Study - Delirium in Elderly paTiEnts Admitted to Trauma

NCT02086981 | Completed

• 1 other identifier: OSS.13.070
• Study Type: observational
• Target: 672
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objectives are to define incidence and prevalence of Delirium in an elderly population admitted to the Department of Orthopedics and Traumatology and, in the postoperative phase, in the high Dependency Unit as well as to determine the presence of risk factors. Secondary objectives are to determine mean hospital stay, rates of complications as well as in-hospital mortality and at 1-3 and 12 months after discharge, functional recovery and cognitive outcomes at 1, 3 and 12 moths follow-up.

Conditions

Delirium; Bone Fractures; Multiple Trauma

Outcome Measures

Primary Outcomes (3)

• Prevalence of Delirium, its association with risk factors and their prognostic value

  Patients are evaluated on admission with: * IqCode * Katz Index of Independence in Activities of Daily Living (ADL) * The Lawton Instrumental Activities of Daily Living (IADL) Scale * The Barthel Index for Mobility * The Confusion Assessment Method (CAM) * The 4AT Scale * Presence of Risk Factors

  At hospital admission

• Incidence of Delirium, its association with risk factors and their prognostic value

  Detection of any change in clinical condition. Patients are evaluated with: * The Confusion Assessment Method (CAM) * The 4AT Scale

  At hospital admission and for the next 48 hours

• Incidence of Delirium, its association with risk factors and their prognostic value

  Detection of any change in clinical condition. Patients are evaluated with: * The Confusion Assessment Method (CAM) * The 4AT Scale

  After surgery and for the next 48 hours

Secondary Outcomes (5)

• Mortality rates

  In-Hospital

• Mortality rates

  At 1,3 and 12 months follow-up

• Mean Hospital Stay

  In-Hospital

• Clinical Complications

  In-Hospital

• Changes in functional capabilities

  At 1, 3 and 12 months follow-up

Other Outcomes (1)

• Variations of serum cystatin C as a marker of glomerular filtration rate and its association with the development of Delirium

  At hospital admission and on the fifth day of hospitalization

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the Department of Orthopedics and Traumatology and in the High Dependency Unit in the postoperative phase

You may qualify if:

• Patients with any medical condition with an age of 65 years and older

You may not qualify if:

• Impossibility to give an informed consent; refusal

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (1)

C.T.O. Azienda Ospedaliero-Universitaria Careggi

Florence, 50134, Italy

Location

MeSH Terms

Conditions

Delirium; Fractures, Bone; Multiple Trauma

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Wounds and Injuries

Study Officials

• Marco Mannucci, MD

  Azienda Ospedaliero-Universitaria Careggi

  STUDY DIRECTOR

• Alessandro Cartei, MD

  Azienda Ospedaliero-Universitaria Careggi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medicina Interna per la Gestione Pre e Postoperatoria Traumatologica e del Percorso Neuromotorio

Study Record Dates

• First Submitted: February 22, 2014
• First Posted: March 14, 2014
• Study Start: February 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: December 29, 2015

Record last verified: 2015-12

Locations

IT (1)