Critical CareNCT03216785
SNUH MICU Cohort Study of PICS
An observational study of Critical Care and Registries, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Prospective registry of patients admitted to the medical intensive care unit Patients discharged are followed up to 5 years after discharge Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Critical Care, Registries
- How many people
- 5,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2017to 1 Jul 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to the medical intensive care unit
Who may be able to join
- Patients admitted to the medical intensive care unit
Who cannot join
- Patients admitted to the intensive care unit for simple procedures
- Patients admitted for postoperative care observation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110744
Jinwoo Lee, Professor, 82-2-2072-7593, realrain7@gmail.com
Sang-Min Lee, M.D., 82-2-2072-0833, sangmin2@snu.ac.kr
About this study
Official title: Cohort Study of Patients Patients in the Medical Intensive Care Unit to Evaluate Postintensive Care Sydnrome
Prospective registry of patients admitted to the medical intensive care unit Patients discharged are followed up to 5 years after discharge
- Conditions
- Critical Care, Registries
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional status
Clinical frailty scale, The de Morton Mobility Index
Measured: 3 month
Secondary outcomes (1)
Survival
Survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start1 Jul 2017
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies 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
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinwoo Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216785
- Sponsor's protocol ID
- 1704140848
- Status last verified
- Aug 2021
- First submitted
- 12 Jul 2017
- Last updated
- 20 Aug 2021
- Results posted
- 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 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Patients Patients in the Medical Intensive Care Unit to Evaluate Postintensive Care Sydnrome
- ClinicalTrials.gov ID
- NCT03216785
- Acronym / sponsor ID
- 1704140848
- Conditions
- Critical Care, Registries
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 13 Jul 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.
Prospective registry of patients admitted to the medical intensive care unit Patients discharged are followed up to 5 years after discharge
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the medical intensive care unit
Key inclusion criteria (1 listed)
- Patients admitted to the medical intensive care unit
Key exclusion criteria (2 listed)
- Patients admitted to the intensive care unit for simple procedures
- Patients admitted for postoperative care observation
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
Functional status
Time frame: 3 month
Clinical frailty scale, The de Morton Mobility Index
1 secondary outcome
Survival
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- 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.
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 Critical Care and Registries, 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: looking for participants now, as of the sponsor's last update on 20 Aug 2021. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinwoo Lee, MD (+82-2-2072-7593, realrain7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional status (time frame: 3 month). 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 20 Aug 2021.