Quality of LifeNCT02521428
End-of-Life Decisions in Surgical Intensive Care Medicine - The Relevance of Treatment Withholding
An observational study of Quality of Life, run by Charite University, Berlin, Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Quality of Life
- What is being tested?
- retrospective analysis
- How many people
- 226 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Aug 2015
- 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 Surgical Intensive Care Department patients will be enrolled in the study
Who may be able to join
- All surgical patients admitted to the ICU All surgical patients discharged death from the ICU
Who cannot join
- All patients discharged alive from the ICU
About this study
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.
Read the 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.
- Conditions
- Quality of Life
- Being tested
- retrospective analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospective analysisOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
sequence of withdrawing life-sustaining treatment
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.
Measured: 3 years
Secondary outcomes (1)
factors associated with the withholding of specific ICU-therapies
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startAug 2008
- Primary completionSep 2011
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Adriaan Graw, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521428
- Sponsor's protocol ID
- EOLD_T
- Status last verified
- Aug 2015
- First submitted
- 9 Aug 2015
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End-of-Life Decisions in Surgical Intensive Care Medicine - The Relevance of Treatment Withholding
- ClinicalTrials.gov ID
- NCT02521428
- Acronym / sponsor ID
- EOLD_T
- Conditions
- Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 13 Aug 2015 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All Surgical Intensive Care Department patients will be enrolled in the study
Key inclusion criteria (1 listed)
- All surgical patients admitted to the ICU All surgical 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retrospective analysisApproximately 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. | Other | – |
Primary outcome
sequence of withdrawing life-sustaining treatment
Time frame: 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.
1 secondary outcome
factors associated with the withholding of specific ICU-therapies
Time frame: 3 years
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 13 Aug 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by Charite University, Berlin, 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 1 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 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
sequence of withdrawing life-sustaining treatment (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2015.