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

Completed

• Conditions: Quality of Life

• Registration Number: NCT02521428
• Lead Sponsor: Charite University, Berlin, Germany

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2011-09
• Status Verified: 2015-08
• Study Completion: 2015-08
• Study First Submitted: 2015-08-09
• Study First Submitted QC: 2015-08-11
• Last Update Submitted: 2015-08-11
• Study First Posted: 2015-08-13
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sequence of withdrawing life-sustaining treatment	3 years	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.

Secondary Outcome Measures

Name	Time	Method
factors associated with the withholding of specific ICU-therapies	3 years	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