Informed Consents for Withholding/Withdrawing Life Support in Intensive Care Units
1 other identifier
observational
348
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 12, 2013
CompletedFirst Posted
Study publicly available on registry
December 25, 2013
CompletedDecember 25, 2013
December 1, 2013
10 months
December 12, 2013
December 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 year after ICU admission
Study Arms (2)
WLS group
patients with informed consents for withholding/withdrawing life support
non-WLS group
patients without informed consents for withholding/withdrawing life support
Eligibility Criteria
patients who died from January 2012 to December 2012 in the surgical or medical Intensive Care Unit (ICU)
You may qualify if:
- 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.
You may not qualify if:
- Patients diagnosed with brain death
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Chief of ICUs, Severance Hospital, Yonsei University Health System
Seoul, 120-752, South Korea
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2013
First Posted
December 25, 2013
Study Start
February 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
December 25, 2013
Record last verified: 2013-12