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

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 Overview

• Status: Completed
• Conditions: Death Occurring in Intensive Care Units

• Study Type: Observational
• Enrollment (Actual): 348

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Chief of ICUs, Severance Hospital, Yonsei University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 92 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: December 12, 2013
• First Submitted That Met QC Criteria: December 18, 2013
• First Posted (Estimate): December 25, 2013

Study Record Updates

• Last Update Posted (Estimate): December 25, 2013
• Last Update Submitted That Met QC Criteria: December 18, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Intensive care unit (ICU); Informed consents; Withholding/withdrawing life support (WLS)
• Other Study ID Numbers: 4-2012-0858