Risk Factors for Delirium in Critically Ill Surgical Patients

Delirium Clinical Trial

Official title:

Risk Factors for Delirium in Critically Ill Surgical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03050021
• Other study ID #: 2014-0251
• Status: Completed
• Phase: N/A
• First received: February 8, 2017
• Last updated: February 8, 2017
• Start date: April 1, 2013
• Est. completion date: August 30, 2015

Study information

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

Clinical Trial Summary

Delirium is characterized by changes in mental status, inattension, disorganized thinking, and altered consciousness. Prevalence of delirium in critically ill patients has varied from 20~80% depending on the severity of illness. Despite its high prevalence, delirium is often under-recognized by clinicians due to the difficulties in diagnosis and no interest. Delirium is associated with increased mechanical ventilation days, hospital length of stay, and mortality. The purpose of this study is to analyze the prevalence of delirium and risk factors for delirium in critically ill surgical patients.

Description:

The investigators performed a prospective cohort study involving the patients admitted to surgical ICU between april 2013 and august 2013.

The included patients were assessed independently by trained ICU nurses using the confusion Assessment Method for the ICU (CAM-ICU). The patients were recorded general characteristics, disease-related factors, and treatment and environment-related factors. Data were analyzed by SPSS 12.0 software, using t-test, Fisher's exact test and logistic regression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: August 30, 2015
• Est. primary completion date: August 30, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Above RASS -3 paitent

2. Verbally or nonverbally communication possible patients

Exclusion Criteria:

1. Under age 18

2. Neurological disorder e.g.) Brain injury, dementia and traumatic brain injury

3. Readmitted to ICU

4. History of delirium

5. Transplanted; isolation is required

Related Conditions & MeSH terms

• Critical Illness
• Delirium
• Intensive Care Unit Syndrome

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Suk-Kyung

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (15)

Bross MH, Tatum NO. Delirium in the elderly patient. Am Fam Physician. 1994 Nov 1;50(6):1325-32. Review. — View Citation

Dubois MJ, Bergeron N, Dumont M, Dial S, Skrobik Y. Delirium in an intensive care unit: a study of risk factors. Intensive Care Med. 2001 Aug;27(8):1297-304. — 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

Gabor JY, Cooper AB, Crombach SA, Lee B, Kadikar N, Bettger HE, Hanly PJ. Contribution of the intensive care unit environment to sleep disruption in mechanically ventilated patients and healthy subjects. Am J Respir Crit Care Med. 2003 Mar 1;167(5):708-15 — View Citation

Gustafson Y, Berggren D, Brännström B, Bucht G, Norberg A, Hansson LI, Winblad B. Acute confusional states in elderly patients treated for femoral neck fracture. J Am Geriatr Soc. 1988 Jun;36(6):525-30. — View Citation

Hsieh SJ, Ely EW, Gong MN. Can intensive care unit delirium be prevented and reduced? Lessons learned and future directions. Ann Am Thorac Soc. 2013 Dec;10(6):648-56. doi: 10.1513/AnnalsATS.201307-232FR. Review. — View Citation

Hunt JM. The cardiac surgical patient's expectations and experiences of nursing care in the intensive care unit. Aust Crit Care. 1999 Jun;12(2):47-53. — View Citation

Irish JT. Deciphering the physician-older patient interaction. Int J Psychiatry Med. 1997;27(3):251-67. Review. — View Citation

Kamdar BB, Needham DM, Collop NA. Sleep deprivation in critical illness: its role in physical and psychological recovery. J Intensive Care Med. 2012 Mar-Apr;27(2):97-111. doi: 10.1177/0885066610394322. — View Citation

Micek ST, Anand NJ, Laible BR, Shannon WD, Kollef MH. Delirium as detected by the CAM-ICU predicts restraint use among mechanically ventilated medical patients. Crit Care Med. 2005 Jun;33(6):1260-5. — View Citation

Peterson JF, Pun BT, Dittus RS, Thomason JW, Jackson JC, Shintani AK, Ely EW. Delirium and its motoric subtypes: a study of 614 critically ill patients. J Am Geriatr Soc. 2006 Mar;54(3):479-84. — View Citation

Pisani MA, Araujo KL, Van Ness PH, Zhang Y, Ely EW, Inouye SK. A research algorithm to improve detection of delirium in the intensive care unit. Crit Care. 2006;10(4):R121. — View Citation

Pisani MA, Kong SY, Kasl SV, Murphy TE, Araujo KL, Van Ness PH. Days of delirium are associated with 1-year mortality in an older intensive care unit population. Am J Respir Crit Care Med. 2009 Dec 1;180(11):1092-7. doi: 10.1164/rccm.200904-0537OC. — View Citation

Rapp CG, Mentes JC, Titler MG. Acute confusion/delirium protocol. J Gerontol Nurs. 2001 Apr;27(4):21-33; quiz 62-3. — 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 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevelance of delirium	Analyses were performed to delirium prevelance of SICU Patients	with in 6month in SICU
Secondary	Risk factors associated with delirium	Analyses were performed to compare patient, disease, treatment and environment-related factors	with in 6month in SICU