DeliriumNCT03199859
Early Diagnosis and Treatment Standardization of Delirium
An observational study of Delirium, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
1. Observe the characteristics of delirium patients, searching for early diagnostic methods or finding risk factors 2. Design a guideline for delirium, diagnosis or treatment Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium
- How many people
- 250 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 May 2016to 31 Dec 2018
- How long will I take part?
- 12 Months
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients admitted to the gastric cancer department of general surgery at Seoul National University Hospital due for surgical resection were included.
Who may be able to join
- Curable malignant gastric cancer
Who cannot join
- Gastrointestinal stromal tumor
- Uncurable cancer
Trial locations and contacts
1 site in 1 country.
About this study
- Observe the characteristics of delirium patients, searching for early diagnostic methods or finding risk factors
- Design a guideline for delirium, diagnosis or treatment
Read the detailed description
The study is consisted of two parts; First, observational study of gastric cancer patients admitted to hospital, diagnosing the presence of delirium or subsyndromal delirium and collecting patient data, including assessment, self-report surveys, and electronic medical records.
Second, Designing a guideline for treating delirium patients in Korea using the study data and reviewing other studies, guidelines.
- Conditions
- Delirium
- Keywords
- gastric cancer, postoperative, subsyndromal delirium, quality of life
- Medical subject headings
- Delirium, Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium Rating Scale-98
Delirium rating tool, score of 8 for subsyndromal delirium, 15 for delirium
Measured: Till 1 year after surgery
Secondary outcomes (1)
Functional assessment of cancer therapy - gastric cancer
Quality of life measuring tool for gastric cancer
Measured: Till 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start17 May 2016
- Primary completion31 Oct 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bong-Jin Hahm, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199859
- Sponsor's protocol ID
- 072016105
- Status last verified
- Sep 2019
- First submitted
- 22 Jun 2017
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis and Treatment Standardization of Delirium
- ClinicalTrials.gov ID
- NCT03199859
- Acronym / sponsor ID
- 072016105
- Conditions
- Delirium
- Keywords
- gastric cancer, postoperative, subsyndromal delirium, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 17 May 2016 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 27 Jun 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.
- Observe the characteristics of delirium patients, searching for early diagnostic methods or finding risk factors
- Design a guideline for delirium, diagnosis or treatment
Detailed description
The study is consisted of two parts; First, observational study of gastric cancer patients admitted to hospital, diagnosing the presence of delirium or subsyndromal delirium and collecting patient data, including assessment, self-report surveys, and electronic medical records.
Second, Designing a guideline for treating delirium patients in Korea using the study data and reviewing other studies, guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the gastric cancer department of general surgery at Seoul National University Hospital due for surgical resection were included.
Key inclusion criteria (1 listed)
- Curable malignant gastric cancer
Key exclusion criteria (2 listed)
- Gastrointestinal stromal tumor
- Uncurable cancer
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
Delirium Rating Scale-98
Time frame: Till 1 year after surgery
Delirium rating tool, score of 8 for subsyndromal delirium, 15 for delirium
1 secondary outcome
Functional assessment of cancer therapy - gastric cancer
Time frame: Till 1 year after surgery
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 23 Sep 2019.
- Individual participant dataSharing planned: No
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The Danish Out-of-Hospital Cardiac Arrest Study
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Seoul National University Hospital 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 1 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 23 Sep 2019. 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?
Delirium Rating Scale-98 (time frame: Till 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2019; AzTrials last refreshed its copy on 7 Nov 2026.