DeathNCT01294189
Advance Directives and End-of-life Decision Making in Intensive Care Medicine in Germany
An observational study of Death, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Death
- How many people
- 224 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2008to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All intensive care department patients (MAN101i and MAN103i Charité Berlin) will be enrolled in the study
Who may be able to join
- All patients admitted to the ICU
- All patients discharged death from the ICU
Who cannot join
- All patients discharged alive from the ICU
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte
Berlin, State of Berlin, 10117
About this study
Official title: The Impact of Instituting a Law for Advance Directives on End-of-life Decision Making in Intensive Care Medicine in Germany
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.
Read the 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.
- Conditions
- Death
- Keywords
- end-of-life decisions, critical care, advance directive
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 08/2008 - 09/2010
Secondary outcomes (2)
influence of the new German advance directives law on end-of-life decisions
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.
Measured: 08/2008 - 09/2010
the process of end-of-life decisions on a German intensive care unit
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.
Measured: 08/2008 - 09/2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startAug 2008
- Primary completionSep 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeathStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Jan-Peter Braun, MD, Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294189
- Sponsor's protocol ID
- EOLD
- Status last verified
- Jan 2011
- First submitted
- 10 Feb 2011
- Last updated
- 11 Feb 2011
- Results posted
- No
Publications
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.
PubMed 23049701
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Instituting a Law for Advance Directives on End-of-life Decision Making in Intensive Care Medicine in Germany
- ClinicalTrials.gov ID
- NCT01294189
- Acronym / sponsor ID
- EOLD
- Conditions
- Death
- Keywords
- end-of-life decisions, critical care, advance directive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 11 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All intensive care department patients (MAN101i and MAN103i Charité Berlin) will be enrolled in the study
Key inclusion criteria (2 listed)
- All patients admitted to the ICU
- All patients discharged death from the ICU
Key exclusion criteria (1 listed)
- All patients discharged alive from the ICU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
influence of the new German advance directives law on end-of-life decisions
Time frame: 08/2008 - 09/2010
the process of end-of-life decisions on a German intensive care unit
Time frame: 08/2008 - 09/2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2011.
- Derived from this study: PubMed 23049701Graw 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan-Peter Braun, MD study director
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Death, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decision makers of end-of-life decisions (time frame: 08/2008 - 09/2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01294189, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2011.