Incidence and Risk Factors for Delirium in Severely Injured Patients

Delirium Clinical Trial

Official title:

Incidence and Risk Factors for Delirium in Severely Injured Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03023839
• Other study ID #: 2014-0344
• Status: Completed
• Phase: N/A
• First received: January 10, 2017
• Last updated: January 17, 2017
• Start date: February 2015
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This study was a prospective cohort study that reviewed the medical records of 179 trauma patients who were admitted to Asan Medical Center from January 01, 2013 to December 31, 2014. The investigators included all patients who had an Injury Severity Score (ISS) of more than 15 and excluded patients younger than 15 years old. This study was approved by the Asan Medical Center Institutional Review Board (2014-0344).

Patient delirium was checked using the Confusion Assessment Method in Intensive Care Unit (CAM-ICU) three times every day. The CAM-ICU includes four features that assess acute changes in or the fluctuating course of mental status, inattention, altered level of consciousness, and disorganized thinking. If a patient has a Richmond Agitation Sedation Scale (RASS) score of -3 or more with acute changes in mental status, inattention, and disorganized thinking or altered level of consciousness, a diagnosis of delirium can be made. The investigators considered patients to be delirious when CAM-ICU was positive for more than 24 h.

The investigators reviewed clinical information for the study patients including age, sex, and underlying disease. Trauma factors reviewed were cause of trauma, ISS, Glasgow Coma Scale (GCS) score, shock, initial lactate level, massive transfusion within 24 h, cardiopulmonary resuscitation rescue, and time taken to the hospital after trauma. Factors related to treatment included use of restraints, mechanical ventilation, and surgery. Clinical outcomes included mortality, ICU stay, mechanical ventilation duration, and hospital stay.

Statistical analysis were done using both univariate (chi-square test and t-test) and multivariate (logistic regression) procedures. Results are reported as mean ± standard deviation. Significance set at a P value of less than .05. For the multivariable logistic regression, the primary outcome variable of interest was the development of delirium after trauma that was classified as either present or absent. Variables were entered for analysis based on the strength of their univariate association with the presence/absence of delirium.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: January 2017
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• age under 15

Related Conditions & MeSH terms

• Delirium
• Intensive Care Unit Syndrome
• Trauma

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Mistraletti G, Carloni E, Cigada M, Zambrelli E, Taverna M, Sabbatici G, Ombrello M, Elia G, Destrebecq AL, Iapichino G. Sleep and delirium in the intensive care unit. Minerva Anestesiol. 2008 Jun;74(6):329-33. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of delirium in trauma patients		within the 6 months after ICU admission
Primary	risk factors of delirium in trauma patients		within the 6 months after ICU admission
Secondary	hospital stay of delirium in trauma patients		within the 6 months after ICU admission
Secondary	ICU stay of delirium in trauma patients		within the 6 months after ICU admission
Secondary	mechanical ventilation days of delirium in trauma patients		within the 6 months after ICU admission
Secondary	mortality of delirium in trauma patients		within the 6 months after ICU admission