Death Occurring in Intensive Care UnitsNCT02020473
Informed Consents for Withholding/Withdrawing Life Support in Intensive Care Units
An observational study of Death Occurring in Intensive Care Units, run by Yonsei University at 1 site in South Korea.
Trial summary
End-of- life care is a major issue in medical ethics with life support technology progress. Intensive care may prolong the dying process in patients who have been unresponsive to the treatment already provided. Read more about this study
- Who is it for?
- Ages Up to 92 years
- Conditions the study is for
- Death Occurring in Intensive Care Units
- How many people
- 348 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2013to Dec 2013
- 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 Up to 92 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who died from January 2012 to December 2012 in the surgical or medical Intensive Care Unit (ICU)
Who may be able to join
- patients who died from January 2012 to December 2012 in the surgical or medical Intensive Care Unit (ICU) at Severance Hospital, Yonsei University Health System, in Seoul, Korea.
Who cannot join
- Patients diagnosed with brain death
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Chief of ICUs, Severance Hospital, Yonsei University Health System
Seoul, 120-752
About this study
End-of- life care is a major issue in medical ethics with life support technology progress. Intensive care may prolong the dying process in patients who have been unresponsive to the treatment already provided. Withholding or withdrawing of life support (WLS) care was introduced to avoid the suffering of critically ill patients. Decision to WLS is a difficult and affected by several factors including not only disease severity but also ethics, religion, culture, and legal background. In western countries, advance directives had an important role to WLS for dying patients and honor patient autonomy. However, the illegality of advance directives in Korea and Korean culture under Confucianism, requiring children to do the best to treat their parents in the name of filial piety make physicians and family members difficult to WLS in terminally ill patients.
Additionally, WLS in intensive care unit had been usually decided without official documentation before the final legal decision by Supreme Court in Korea. Scanty information exists about end-of-life practices because informed consents of WLS were taken after the legal decision.
Thus, we aimed to investigate the current status of informed consent at the time of decision to WLS and difference between WLS group and non-WLS group in Korea.
- Conditions
- Death Occurring in Intensive Care Units
- Keywords
- Informed consents, Withholding/withdrawing life support (WLS), Intensive care unit (ICU)
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 |
|---|---|---|
| WLS group | patients with informed consents for withholding/withdrawing life support | |
| non-WLS group | patients without informed consents for withholding/withdrawing life support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signing of informed consents for withholding/withdrawing life support
Primary outcome was existence of informed consents for withholding/withdrawing life support. Data from informed consents for WLS included main family members who signed the WLS and type of the life support modalities withheld or withdrawn.
Measured: 1 year after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Death Occurring in Intensive Care UnitsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Retrospective
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020473
- Sponsor's protocol ID
- 4-2012-0858
- Status last verified
- Dec 2013
- First submitted
- 12 Dec 2013
- Last updated
- 25 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Informed Consents for Withholding/Withdrawing Life Support in Intensive Care Units
- ClinicalTrials.gov ID
- NCT02020473
- Acronym / sponsor ID
- 4-2012-0858
- Conditions
- Death Occurring in Intensive Care Units
- Keywords
- Informed consents, Withholding/withdrawing life support (WLS), Intensive care unit (ICU)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Dec 2013 (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.
End-of- life care is a major issue in medical ethics with life support technology progress. Intensive care may prolong the dying process in patients who have been unresponsive to the treatment already provided. Withholding or withdrawing of life support (WLS) care was introduced to avoid the suffering of critically ill patients. Decision to WLS is a difficult and affected by several factors including not only disease severity but also ethics, religion, culture, and legal background. In western countries, advance directives had an important role to WLS for dying patients and honor patient autonomy. However, the illegality of advance directives in Korea and Korean culture under Confucianism, requiring children to do the best to treat their parents in the name of filial piety make physicians and family members difficult to WLS in terminally ill patients.
Additionally, WLS in intensive care unit had been usually decided without official documentation before the final legal decision by Supreme Court in Korea. Scanty information exists about end-of-life practices because informed consents of WLS were taken after the legal decision.
Thus, we aimed to investigate the current status of informed consent at the time of decision to WLS and difference between WLS group and non-WLS group in Korea.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WLS group | – | –patients with informed consents for withholding/withdrawing life support |
| non-WLS group | – | –patients without informed consents for withholding/withdrawing life support |
Who may qualify
- Ages
- Up to 92 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who died from January 2012 to December 2012 in the surgical or medical Intensive Care Unit (ICU)
Key inclusion criteria (1 listed)
- patients who died from January 2012 to December 2012 in the surgical or medical Intensive Care Unit (ICU) at Severance Hospital, Yonsei University Health System, in Seoul, Korea.
Key exclusion criteria (1 listed)
- Patients diagnosed with brain death
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
Signing of informed consents for withholding/withdrawing life support
Time frame: 1 year after ICU admission
Primary outcome was existence of informed consents for withholding/withdrawing life support. Data from informed consents for WLS included main family members who signed the WLS and type of the life support modalities withheld or withdrawn.
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 25 Dec 2013.
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Recruiting
The Effect of Mindfulness-Based Death Psychoeducation Program on Death Awareness and Death Anxiety Levels in Nurses
Death Anxiety, Death Occurring in Intensive Care Units
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 Death Occurring in Intensive Care Units, run by Yonsei University 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 1 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 25 Dec 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 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?
Signing of informed consents for withholding/withdrawing life support (time frame: 1 year after ICU admission). 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 25 Dec 2013.