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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01294189
First Posted: February 11, 2011
Last Update Posted: February 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Charite University, Berlin, Germany
  Purpose
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.

Condition
Death

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: The Impact of Instituting a Law for Advance Directives on End-of-life Decision Making in Intensive Care Medicine in Germany

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • decision makers of end-of-life decisions [ Time Frame: 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:
  • influence of the new German advance directives law on end-of-life decisions [ Time Frame: 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 [ Time Frame: 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.



Enrollment: 224
Study Start Date: August 2008
Study Completion Date: February 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
ICU-patients that died on the ICU
ICU-patients (post-operative and non operative patients) will be enrolled in the study. All patients are followed until their death on the ICU.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All intensive care department patients (MAN101i and MAN103i Charité Berlin) will be enrolled in the study
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • All patients discharged alive from the ICU
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01294189


Locations
Germany
Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Study Director: Jan-Peter Braun, MD Charite University, Berlin, Germany
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Priv.-Doz. Dr. Jan-Peter Braun, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01294189     History of Changes
Other Study ID Numbers: EOLD
First Submitted: February 10, 2011
First Posted: February 11, 2011
Last Update Posted: February 11, 2011
Last Verified: January 2011

Keywords provided by Charite University, Berlin, Germany:
end-of-life decisions, critical care, advance directive