DeliriumNCT03050021
Risk Factors for Delirium in Critically Ill Surgical Patients
An observational study of Delirium and Intensive Care Unit Syndrome, run by Suk-Kyung at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Intensive Care Unit Syndrome
- How many people
- 251 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2013to 30 Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Admitted to the surgical ICU from April to August 2013 and had the ability to express themselves verbally or nonverbally.
Who may be able to join
- Above RASS -3 paitent
- Verbally or nonverbally communication possible patients
Who cannot join
- Under age 18
- Neurological disorder e.g.) Brain injury, dementia and traumatic brain injury
- Readmitted to ICU
- History of delirium
- Transplanted; isolation is required
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Delirium, Intensive Care Unit Syndrome
- Keywords
- Delirium, Intensive care unit
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Delirium positive | delirium patients in critically ill surgical patients | |
| Delirium negative | non delirium patients in critically ill surgical patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevelance of delirium
Analyses were performed to delirium prevelance of SICU Patients
Measured: with in 6month in SICU
Secondary outcomes (1)
Risk factors associated with delirium
Analyses were performed to compare patient, disease, treatment and environment-related factors
Measured: with in 6month in SICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start1 Apr 2013
- Primary completion30 Aug 2013
- Study completion30 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suk-Kyung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Suk-Kyung, Asan Medical Center
- Investigators
- Suk-kyung Hong, Ph.D, Principal investigator, University of Ulsan College of Medicine. Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050021
- Sponsor's protocol ID
- 2014-0251
- Status last verified
- Feb 2017
- First submitted
- 8 Feb 2017
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11511942Ely 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.
PubMed 15082703Pisani 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.
PubMed 16919169Pisani 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.
PubMed 19745202Hsieh 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.
PubMed 24364769Rapp 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.
PubMed 11915153Thomason 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.
PubMed 16137350Hunt 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.
PubMed 10624186Peterson 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.
PubMed 16551316Irish JT. Deciphering the physician-older patient interaction. Int J Psychiatry Med. 1997;27(3):251-67. doi: 10.2190/CQ97-Y82H-6P2E-9BJ4.
PubMed 9565727Gustafson 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.
PubMed 2897391Micek 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.
PubMed 15942341Kamdar 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.
PubMed 21220271Gabor 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.
PubMed 12598213Bross MH, Tatum NO. Delirium in the elderly patient. Am Fam Physician. 1994 Nov 1;50(6):1325-32.
PubMed 7942430
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Delirium in Critically Ill Surgical Patients
- ClinicalTrials.gov ID
- NCT03050021
- Acronym / sponsor ID
- 2014-0251
- Conditions
- Delirium, Intensive Care Unit Syndrome
- Keywords
- Delirium, Intensive care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Suk-KyungUniversity, hospital or other
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 30 Aug 2013 (actual)
- Study completion
- 30 Aug 2015 (actual)
- First posted
- 10 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delirium positive | – | –delirium patients in critically ill surgical patients |
| Delirium negative | – | –non delirium patients in critically ill surgical patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Admitted to the surgical ICU from April to August 2013 and had the ability to express themselves verbally or nonverbally.
Key inclusion criteria (2 listed)
- Above RASS -3 paitent
- Verbally or nonverbally communication possible patients
Key exclusion criteria (5 listed)
- Under age 18
- Neurological disorder e.g.) Brain injury, dementia and traumatic brain injury
- Readmitted to ICU
- History of delirium
- Transplanted; isolation is required
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevelance of delirium
Time frame: with in 6month in SICU
Analyses were performed to delirium prevelance of SICU Patients
1 secondary outcome
Risk factors associated with delirium
Time frame: with in 6month in SICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Results publication: PubMed 11511942Dubois 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.
- Results publication: PubMed 15082703Ely 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.
- Results publication: PubMed 16919169Pisani 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.
- Results publication: PubMed 19745202Pisani 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.
- Results publication: PubMed 24364769Hsieh 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.
- Results publication: PubMed 11915153Rapp 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.
- Results publication: PubMed 16137350Thomason 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.
- Results publication: PubMed 10624186Hunt 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.
- Results publication: PubMed 16551316Peterson 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.
- Results publication: PubMed 9565727Irish JT. Deciphering the physician-older patient interaction. Int J Psychiatry Med. 1997;27(3):251-67. doi: 10.2190/CQ97-Y82H-6P2E-9BJ4.
- Results publication: PubMed 2897391Gustafson 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.
- Results publication: PubMed 15942341Micek 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suk-kyung Hong, Ph.D principal investigator
University of Ulsan College of Medicine. Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Intensive Care Unit Syndrome, run by Suk-Kyung at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevelance of delirium (time frame: with in 6month in SICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03050021, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.