NCT03050021

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
251

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2017

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

5 months

First QC Date

February 8, 2017

Last Update Submit

February 8, 2017

Conditions

DeliriumIntensive Care Unit Syndrome

Keywords

DeliriumIntensive care unit

Outcome Measures

Primary Outcomes (1)

  • Prevelance of delirium

    Analyses were performed to delirium prevelance of SICU Patients

    with in 6month in SICU

Secondary Outcomes (1)

  • Risk factors associated with delirium

    with in 6month in SICU

Study Arms (2)

Delirium positive

delirium patients in critically ill surgical patients

Delirium negative

non delirium patients in critically ill surgical patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Admitted to the surgical ICU from April to August 2013 and had the ability to express themselves verbally or nonverbally.

You may qualify if:

  • Above RASS -3 paitent
  • Verbally or nonverbally communication possible patients

You may not qualify if:

  • Under age 18
  • Neurological disorder e.g.) Brain injury, dementia and traumatic brain injury
  • Readmitted to ICU
  • History of delirium
  • Transplanted; isolation is required

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Seoul, 05505, South Korea

Location

Related Publications (15)

  • 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. doi: 10.1007/s001340101017.

    PMID: 11511942RESULT

  • 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: 15082703RESULT

  • 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. doi: 10.1186/cc5027.

    PMID: 16919169RESULT

  • 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. Epub 2009 Sep 10.

    PMID: 19745202RESULT

  • 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.

    PMID: 24364769RESULT

  • Rapp CG, Mentes JC, Titler MG. Acute confusion/delirium protocol. J Gerontol Nurs. 2001 Apr;27(4):21-33; quiz 62-3. doi: 10.3928/0098-9134-20010401-07.

    PMID: 11915153RESULT

  • 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: 16137350RESULT

  • 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. doi: 10.1016/s1036-7314(99)70535-7.

    PMID: 10624186RESULT

  • 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. doi: 10.1111/j.1532-5415.2005.00621.x.

    PMID: 16551316RESULT

  • Irish JT. Deciphering the physician-older patient interaction. Int J Psychiatry Med. 1997;27(3):251-67. doi: 10.2190/CQ97-Y82H-6P2E-9BJ4.

    PMID: 9565727RESULT

  • Gustafson Y, Berggren D, Brannstrom 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. doi: 10.1111/j.1532-5415.1988.tb04023.x.

    PMID: 2897391RESULT

  • 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. doi: 10.1097/01.ccm.0000164540.58515.bf.

    PMID: 15942341RESULT

  • 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. Epub 2011 Jan 10.

    PMID: 21220271RESULT

  • 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. doi: 10.1164/rccm.2201090.

    PMID: 12598213RESULT

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

    PMID: 7942430RESULT

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental 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
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor in General Surgery

Study Record Dates

First Submitted

February 8, 2017

First Posted

February 10, 2017

Study Start

April 1, 2013

Primary Completion

August 30, 2013

Study Completion

August 30, 2015

Last Updated

February 10, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)