NCT01294189

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2011

Completed
Last Updated

February 11, 2011

Status Verified

January 1, 2011

Enrollment Period

2.1 years

First QC Date

February 10, 2011

Last Update Submit

February 10, 2011

Conditions

Keywords

end-of-life decisions, critical care, advance directive

Outcome Measures

Primary Outcomes (1)

  • decision makers of end-of-life decisions

    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.

    08/2008 - 09/2010

Secondary Outcomes (2)

  • influence of the new German advance directives law on end-of-life decisions

    08/2008 - 09/2010

  • the process of end-of-life decisions on a German intensive care unit

    08/2008 - 09/2010

Study Arms (1)

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All intensive care department patients (MAN101i and MAN103i Charité Berlin) will be enrolled in the study

You may qualify if:

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

You may not qualify if:

  • All patients discharged alive from the ICU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (1)

  • Graw JA, Spies CD, Wernecke KD, Braun JP. Managing end-of-life decision making in intensive care medicine--a perspective from Charite Hospital, Germany. PLoS One. 2012;7(10):e46446. doi: 10.1371/journal.pone.0046446. Epub 2012 Oct 1.

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jan-Peter Braun, MD

    Charite University, Berlin, Germany

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2011

First Posted

February 11, 2011

Study Start

August 1, 2008

Primary Completion

September 1, 2010

Study Completion

February 1, 2011

Last Updated

February 11, 2011

Record last verified: 2011-01

Locations