Advance Directives and End-of-life Decision Making in Intensive Care Medicine in Germany

Completed

• Conditions: Death

• Registration Number: NCT01294189
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

Description of the decision making process as well as the practices of end of life care in an ICU of a German university hospital during the period when changes of German legislation occurred.

Detailed Description

Most patients on the intensive care unit (ICU) die after an end-of-life decision (EOLD) has been made (Sprung et al. 2003). On September 1st 2009 the "advance-directives-law" was inured in Germany considering a written advance directive of an adult binding for physicians and the patient´s surrogate decision makers if it fits into the medical context (BGBL 2009). There is a lack of data describing the process and the factors associated with end-of-life-decisions in ICUs in Germany in detail.

The purpose of this observational study is to describe the decision making process as well as the practices of end of life care in an ICU of a German university hospital during a period when changes of German legislation occurred.

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2010-09
• Status Verified: 2011-01
• Study Completion: 2011-02
• Study First Submitted: 2011-02-10
• Study First Submitted QC: 2011-02-10
• Last Update Submitted: 2011-02-10
• Study First Posted: 2011-02-11
• Last Update Posted: 2011-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

• All patients admitted to the ICU
• All 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
decision makers of end-of-life decisions	08/2008 - 09/2010	The primary objective of this study performed according to an observational post-ad-hoc design is to identify and analyse the decision makers of end-of-life decisions on an intensive care unit in Germany.; Approximately 200 patients will be enrolled in the study. They are followed up until their death on the ICU. Usually in clinical routine end-of-life decisions are documented for decision makers in the patients´ records. The incidences of the different decision makers including members of different clinical specialities and also members with different levels of ICU experience are compared.

Secondary Outcome Measures

Name	Time	Method
influence of the new German advance directives law on end-of-life decisions	08/2008 - 09/2010	The second objective is to investigate what kind of influence the new German law for advance directives had on end-of-life decision making on the ICU.; Approximately 200 patients will be enrolled in the study. They are followed up until their death on the ICU. Usually in clinical routine end-of-life decisions are documented for decision makers and procedures in the patients´ records. The incidences of therapeutic procedures in end of life care comparing patients with advance directives at different time points and those patients without advance directives are reviewed for differences.
the process of end-of-life decisions on a German intensive care unit	08/2008 - 09/2010	Another objective of this study performed according to an observational post-ad-hoc design is to identify and analyse the process of end-of-life decisions on an intensive care unit in Germany.; Approximately 200 patients will be followed up until their death on the ICU. The process of withholding and withdrawing of therapeutic approaches is documented in the patient´s records. The incidences of different therapeutic procedures like ventilation, organ replacement technology, surgery, blood transfusions, antiinfective therapy and nutrition in patients with an EOLD are compared.

Trial Locations

Locations (1)

Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte; 🇩🇪 Berlin, Germany