Incidence and Risk Factors for Delirium in Severely Injured Patients

NCT03023839 | Completed

• 1 other identifier: 2014-0344
• Study Type: observational
• Target: 179
• Locations: 1 country
• Sites: 1

Brief Summary

Delirium is very common in intensive care unit (ICU) patients and leads to poor outcomes. There is little information on delirium in injured patients however. This study determined the incidence and risk factors for delirium in severely injured patients.

Conditions

Delirium; Trauma; Intensive Care Unit Syndrome

Keywords

Delirium; Trauma; Injury; restraints

Outcome Measures

Primary Outcomes (2)

• Incidence of delirium in trauma patients

  within the 6 months after ICU admission

• risk factors of delirium in trauma patients

  within the 6 months after ICU admission

Secondary Outcomes (4)

• hospital stay of delirium in trauma patients

  within the 6 months after ICU admission

• ICU stay of delirium in trauma patients

  within the 6 months after ICU admission

• mechanical ventilation days of delirium in trauma patients

  within the 6 months after ICU admission

• mortality of delirium in trauma patients

  within the 6 months after ICU admission

Study Arms (1)

Severe trauma patients

Severe Trauma patients (ISS \>15) admitted to Intensive Care Unit (ICU)

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Severe Trauma patients admiited to Intensive Care Unit (ICU) of Asan Medical Center from 01 Jan 2013 to 31 Dec 2014

You may qualify if:

• trauma patients with Injury Severity Score (ISS) more than 15

You may not qualify if:

• age under 15

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, Seoul, 05505, South Korea

Location

Related Publications (11)

• Reade MC, Finfer S. Sedation and delirium in the intensive care unit. N Engl J Med. 2014 Jan 30;370(5):444-54. doi: 10.1056/NEJMra1208705. No abstract available.

  PMID: 24476433 BACKGROUND

• Angles EM, Robinson TN, Biffl WL, Johnson J, Moss M, Tran ZV, Moore EE. Risk factors for delirium after major trauma. Am J Surg. 2008 Dec;196(6):864-9; discussion 869-70. doi: 10.1016/j.amjsurg.2008.07.037.

  PMID: 19095101 BACKGROUND

• Thomason JW, Shintani A, Peterson JF, Pun BT, Jackson JC, Ely EW. Intensive care unit delirium is an independent predictor of longer hospital stay: a prospective analysis of 261 non-ventilated patients. Crit Care. 2005 Aug;9(4):R375-81. doi: 10.1186/cc3729. Epub 2005 Jun 1.

  PMID: 16137350 BACKGROUND

• Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.

  PMID: 15082703 BACKGROUND

• Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.

  PMID: 24088092 BACKGROUND

• Pandharipande P, Cotton BA, Shintani A, Thompson J, Pun BT, Morris JA Jr, Dittus R, Ely EW. Prevalence and risk factors for development of delirium in surgical and trauma intensive care unit patients. J Trauma. 2008 Jul;65(1):34-41. doi: 10.1097/TA.0b013e31814b2c4d.

  PMID: 18580517 BACKGROUND

• Ansaloni L, Catena F, Chattat R, Fortuna D, Franceschi C, Mascitti P, Melotti RM. Risk factors and incidence of postoperative delirium in elderly patients after elective and emergency surgery. Br J Surg. 2010 Feb;97(2):273-80. doi: 10.1002/bjs.6843.

  PMID: 20069607 BACKGROUND

• Gani H, Domi R, Kodra N, Prifti P, Naco M, Beqiri V, Torba D, Tare R. The incidence of postoperative delirium in elderly patients after urologic surgery. Med Arch. 2013;67(1):45-7. doi: 10.5455/medarh.2013.67.45-47.

  PMID: 23678839 BACKGROUND

• Cavallazzi R, Saad M, Marik PE. Delirium in the ICU: an overview. Ann Intensive Care. 2012 Dec 27;2(1):49. doi: 10.1186/2110-5820-2-49.

  PMID: 23270646 BACKGROUND

• Mistraletti G, Carloni E, Cigada M, Zambrelli E, Taverna M, Sabbatini G, Umbrello M, Elia G, Destrebecq AL, Iapichino G. Sleep and delirium in the intensive care unit. Minerva Anestesiol. 2008 Jun;74(6):329-33.

  PMID: 18500209 BACKGROUND

• Brummel NE, Girard TD. Preventing delirium in the intensive care unit. Crit Care Clin. 2013 Jan;29(1):51-65. doi: 10.1016/j.ccc.2012.10.007.

  PMID: 23182527 BACKGROUND

MeSH Terms

Conditions

Delirium; Wounds and Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Suk-kyung Hong, Ph.D

  University of Ulsan College of Medicine. Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 18, 2017
• Study Start: February 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: January 1, 2017
• Last Updated: January 19, 2017

Record last verified: 2017-01

Locations

KR (1)