NCT02020473

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
348

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 25, 2013

Completed
Last Updated

December 25, 2013

Status Verified

December 1, 2013

Enrollment Period

10 months

First QC Date

December 12, 2013

Last Update Submit

December 18, 2013

Conditions

Keywords

Informed consentsWithholding/withdrawing life support (WLS)Intensive care unit (ICU)

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

AgeUp to 92 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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

Locations