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Informed Consents for Withholding/Withdrawing Life Support in Intensive Care Units

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ClinicalTrials.gov Identifier: NCT02020473
Recruitment Status : Completed
First Posted : December 25, 2013
Last Update Posted : December 25, 2013
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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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.


Condition or disease
Death Occurring in Intensive Care Units

Study Design
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Study Type : Observational
Actual Enrollment : 348 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : February 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013
Groups and Cohorts
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Group/Cohort
WLS group
patients with informed consents for withholding/withdrawing life support
non-WLS group
patients without informed consents for withholding/withdrawing life support


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   up to 92 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients who died from January 2012 to December 2012 in the surgical or medical Intensive Care Unit (ICU)
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients diagnosed with brain death
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020473


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Chief of ICUs, Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02020473    
Other Study ID Numbers: 4-2012-0858
First Posted: December 25, 2013    Key Record Dates
Last Update Posted: December 25, 2013
Last Verified: December 2013
Keywords provided by Yonsei University:
Informed consents
Withholding/withdrawing life support (WLS)
Intensive care unit (ICU)