End-of-Life Decisions in Surgical Intensive Care Medicine - The Relevance of Treatment Withholding

Quality of Life Clinical Trial

Official title:

End-of-Life Decisions in Surgical Intensive Care Medicine - The Relevance of Treatment Withholding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02521428
• Other study ID #: EOLD_T
• Status: Completed
• Phase: N/A
• First received: August 9, 2015
• Last updated: August 11, 2015
• Start date: August 2008
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

The purpose of this retrospective observational study is to describe the sequence of ICU-therapies that are limited and to compare characteristics and the decision making process in surgical ICU-patients.

Description:

Decisions to limit life-support therapy are common on the intensive care unit (ICU). End-of-life decisions (EOLD) underlie a dynamic process and limitation of ICU-therapies is done sequentially. Questionnaire-based and observational studies on medical ICUs and in palliative care reveal blood transfusions as the first therapy physicians withhold in EOLDs. Whether this practice also applies to surgical ICU-patients is unknown.

The purpose of this retrospective observational study is to describe the sequence of ICU-therapies that are limited and to compare characteristics and the decision making process in surgical ICU-patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: August 2015
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All surgical patients admitted to the ICU All surgical patients discharged death from the ICU

Exclusion Criteria:

• All patients discharged alive from the ICU

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Quality of Life

Intervention

Other:
• retrospective analysis
Approximately 200 patients will be enrolled in the study. They are followed up until their death on the ICU. In clinical routine end-of-life decisions are documented for decision-makers and procedures in the patients´ records. Patients´ characteristics and therapeutic approaches are documented in the electronic patient data management system.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sequence of withdrawing life-sustaining treatment	The primary objective of this study performed according to an observational post-ad-hoc design is to identify the sequence of withdrawing life-sustaining treatment in surgical ICU-patients with an end-of-life decision on an intensive care unit of a German academic medical center.; Approximately 200 patients will be enrolled in the study. They are followed up until their death on the ICU. In clinical routine end-of-life decisions are documented for decision-makers and procedures in the patients´ records. Patients´ characteristics and therapeutic approaches are documented in the electronic patient data management system.	3 years	No
Secondary	factors associated with the withholding of specific ICU-therapies	Approximately 200 patients will be enrolled in the study. They are followed up until their death on the ICU. In routine end-of-life decisions are documented for decision-makers and procedures in the patients´ records. Patients´ characteristics and therapeutic approaches are documented in the electronic patient data management system	3 years	No