DeliriumZZH-2NCT01616914
Subclinical Delirium and Clinical Outcome
An observational study of Delirium, run by Jinhua Central Hospital at 1 site in China.
Trial summary
Delirium has been associated with clinical outcomes in critical care setting. However, its subclinical form has not been investigated. The investigators aimed to establish the association of subclinical delirium with outcome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Delirium
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Aug 2012
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients enter ICU GCS > 10 RASS > -2 No dementia
Who may be able to join
- patients enter ICU
- GCS > 10
- RASS > -2
Who cannot join
- unable to cooperate
- coma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Delirium and Clinical Outcome
Delirium has been associated with clinical outcomes in critical care setting. However, its subclinical form has not been investigated. The investigators aimed to establish the association of subclinical delirium with outcome.
Read the detailed description
Delirium has been associated with clinical outcome in critical care setting. This syndrome has been associated with longer length of stay in ICU and hospital, longer duration of mechanical ventilation and higher mortality rate. however, its subclinical form has not been investigated. The subclinical syndrome is defined by CAM-ICU, in which several features of delirium are fulfilled but the diagnostic criteria are not fulfilled. The investigators aimed to establish the association of subclinical delirium with outcome.
- Conditions
- Delirium
- Keywords
- delirium, outcome
- 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 group | patients with delirium during ICU stay | |
| non-delirium group | patients without delirium during ICU stay |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
60 days after enrollment
Measured: during hospital stay(60 days)
Secondary outcomes (2)
duration of mechanical ventilation
Measured: 60 days
length of stay in ICU and hospital
Measured: 60 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startJan 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinhua Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongheng Zhang, Jinhua Central Hospital
- Investigators
- Zhongheng Zhang, MM, Study chair, Jinhua Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616914
- Sponsor's protocol ID
- ZZH-2
- Acronym
- ZZH-2
- Status last verified
- Jun 2012
- First submitted
- 7 Jun 2012
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van den Boogaard M, Pickkers P, Slooter AJ, Kuiper MA, Spronk PE, van der Voort PH, van der Hoeven JG, Donders R, van Achterberg T, Schoonhoven L. Development and validation of PRE-DELIRIC (PREdiction of DELIRium in ICu patients) delirium prediction model for intensive care patients: observational multicentre study. BMJ. 2012 Feb 9;344:e420. doi: 10.1136/bmj.e420.
PubMed 22323509van den Boogaard M, Schoonhoven L, van der Hoeven JG, van Achterberg T, Pickkers P. Incidence and short-term consequences of delirium in critically ill patients: A prospective observational cohort study. Int J Nurs Stud. 2012 Jul;49(7):775-83. doi: 10.1016/j.ijnurstu.2011.11.016. Epub 2011 Dec 22.
PubMed 22197051Tomasi CD, Grandi C, Salluh J, Soares M, Giombelli VR, Cascaes S, Macedo RC, de Souza Constantino L, Biff D, Ritter C, Dal Pizzol F. Comparison of CAM-ICU and ICDSC for the detection of delirium in critically ill patients focusing on relevant clinical outcomes. J Crit Care. 2012 Apr;27(2):212-7. doi: 10.1016/j.jcrc.2011.05.015. Epub 2011 Jul 6.
PubMed 21737237
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delirium and Clinical Outcome
- ClinicalTrials.gov ID
- NCT01616914
- Acronym / sponsor ID
- ZZH-2 / ZZH-2
- Conditions
- Delirium
- Keywords
- delirium, outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Jinhua Central HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 12 Jun 2012 (estimated)
- 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 has been associated with clinical outcomes in critical care setting. However, its subclinical form has not been investigated. The investigators aimed to establish the association of subclinical delirium with outcome.
Detailed description
Delirium has been associated with clinical outcome in critical care setting. This syndrome has been associated with longer length of stay in ICU and hospital, longer duration of mechanical ventilation and higher mortality rate. however, its subclinical form has not been investigated. The subclinical syndrome is defined by CAM-ICU, in which several features of delirium are fulfilled but the diagnostic criteria are not fulfilled. The investigators aimed to establish the association of subclinical delirium with outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| delirium group | – | –patients with delirium during ICU stay |
| non-delirium group | – | –patients without delirium during ICU stay |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients enter ICU GCS > 10 RASS > -2 No dementia
Key inclusion criteria (3 listed)
- patients enter ICU
- GCS > 10
- RASS > -2
Key exclusion criteria (2 listed)
- unable to cooperate
- coma
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
mortality
Time frame: during hospital stay(60 days)
60 days after enrollment
2 secondary outcomes
duration of mechanical ventilation
Time frame: 60 days
length of stay in ICU and hospital
Time frame: 60 days after enrollment
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 4 Apr 2013.
- Background: PubMed 22323509van den Boogaard M, Pickkers P, Slooter AJ, Kuiper MA, Spronk PE, van der Voort PH, van der Hoeven JG, Donders R, van Achterberg T, Schoonhoven L. Development and validation of PRE-DELIRIC (PREdiction of DELIRium in ICu patients) delirium prediction model for intensive care patients: observational multicentre study. BMJ. 2012 Feb 9;344:e420. doi: 10.1136/bmj.e420.
- Background: PubMed 22197051van den Boogaard M, Schoonhoven L, van der Hoeven JG, van Achterberg T, Pickkers P. Incidence and short-term consequences of delirium in critically ill patients: A prospective observational cohort study. Int J Nurs Stud. 2012 Jul;49(7):775-83. doi: 10.1016/j.ijnurstu.2011.11.016. Epub 2011 Dec 22.
- Background: PubMed 21737237Tomasi CD, Grandi C, Salluh J, Soares M, Giombelli VR, Cascaes S, Macedo RC, de Souza Constantino L, Biff D, Ritter C, Dal Pizzol F. Comparison of CAM-ICU and ICDSC for the detection of delirium in critically ill patients focusing on relevant clinical outcomes. J Crit Care. 2012 Apr;27(2):212-7. doi: 10.1016/j.jcrc.2011.05.015. Epub 2011 Jul 6.
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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.
Zhongheng Zhang, MM study chair
Jinhua Central Hospital
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, run by Jinhua Central Hospital at 1 site in China.
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 3 inclusion and 2 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 4 Apr 2013. 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 China. 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?
mortality (time frame: during hospital stay(60 days)). 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 NCT01616914, which also lists 3 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 4 Apr 2013.