Withdrawing TreatmentNCT00177606
Donors After Cardiac Death: Validating Identification Criteria
An observational study of Withdrawing Treatment, run by University of Pittsburgh at 4 sites in United States.
Trial summary
The purpose of this study is to validate a set of proposed clinical criteria that have been designed to identify patients who will die rapidly following the elective removal of life sustaining treatments. Read more about this study
- Who is it for?
- Ages Up to 90 years
- Conditions the study is for
- Withdrawing Treatment
- What is being tested?
- withdrawal of life sustaining treatments
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 600 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2003to Dec 2007
- 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 Up to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all patients who have life sustaining treatments withdrawn
Who cannot join
- confirmed brain death
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Case Western Reserve University
Cleveland, Ohio, 44106
Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
The purpose of this study is to validate a set of proposed clinical criteria that have been designed to identify patients who will die rapidly following the elective removal of life sustaining treatments.
Read the detailed description
Our study is a simple, observational study. We intend to record the events that occur between the time withdrawal of life sustaining treatment occurs, and the time of death. Our preliminary data, reported in the journals Critical Care Medicine and Pediatric Critical Care Medicine, show that the median time to death is about 25 minutes, and few survive over an hour. We would directly observe no patient for longer than one hour.
This is a straightforward study to characterize the Receiver Operator Characteristic (ROC) curves and Relative Risk of a variety of clinical data elements for predicting early death following discontinuation of life sustaining treatments. This is a multi-center study currently being conducted at: University of Cincinnati Hospital, Case-Western Reserve University Hospital and the University of Pittsburgh Medical Center with the University of Pittsburgh acting as the Coordinating Center. (a) This is a prospective cohort study of patients electively withdrawn from life sustaining treatment. The investigators and the study have no impact on the decision or timing of withdrawal of support. The study will merely record what and what time support is withdrawn, the medications that are provided for patient comfort, and the time of death. Within this group, we will determine whether patients who "meet" the UNOS criteria (UNOS cohort) have a short time to death, enabling us to validate the current, unvalidated UNOS criteria. In addition, we will analyze data from all patients, perform logistic regression to determine other candidate criteria for determining short time to death. (b) Data extractors will collect the data from all identified patients using chart review following procedures approved by their institutional review board. Data forms will be de-identified at each institution prior to transmission to our central database to ensure patient confidentiality.
The results from the project we are proposing will enable more accurate identification of appropriate candidates for NHBOD. We plan to do this by examining pre-mortem data of patients that have died after withdrawal of LST to see if any factors or combination of factors are predictive of death in less than 30 minutes and 60 minutes after LST is removed.
Our research questions are:
- Do the UNOS criteria predict early death following discontinuation of LST? 2. In addition we will collect data to enable us to address the secondary questions:
- a. What are the best predictors of early death following discontinuation of LST?, and 2.b. How accurate are they?
We intend to test the following two hypotheses:
H1: The UNOS criteria are predictive of death in less than 30 minutes; H2: The UNOS criteria are predictive of death within 60 minutes.
The researchers selected the following outcomes for the study. Outcome 1: death within 30 minutes of removal of life sustaining treatment. Outcome 2: death within 60 minutes of removal of life sustaining treatment. Outcome 3: number of potential organ donors following cardiac death
- Conditions
- Withdrawing Treatment
- Being tested
- withdrawal of life sustaining treatments
- Keywords
- withdrawal, life-sustaining, treatments, UNOS, organ donation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
withdrawal of life sustaining treatmentsBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJul 2003
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Withdrawing TreatmentStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Time perspective
- Prospective
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Responsible party
- Sponsor
- Investigators
- Michael A DeVita, MD, Study chair, University of Pittsburgh/University of Pittsburgh Medical CenterChristine Zowistowski, MD, Principal investigator, University of Tennesse, MemphisMaria Brooks, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00177606
- Sponsor's protocol ID
- 0409061
- Status last verified
- Mar 2008
- First submitted
- 13 Sep 2005
- Last updated
- 31 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donors After Cardiac Death: Validating Identification Criteria
- ClinicalTrials.gov ID
- NCT00177606
- Acronym / sponsor ID
- 0409061
- Conditions
- Withdrawing Treatment
- Keywords
- withdrawal, life-sustaining, treatments, UNOS, organ donation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- Jul 2003
- Study completion
- Dec 2007 (actual)
- First posted
- 15 Sep 2005 (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 study is to validate a set of proposed clinical criteria that have been designed to identify patients who will die rapidly following the elective removal of life sustaining treatments.
Detailed description
Our study is a simple, observational study. We intend to record the events that occur between the time withdrawal of life sustaining treatment occurs, and the time of death. Our preliminary data, reported in the journals Critical Care Medicine and Pediatric Critical Care Medicine, show that the median time to death is about 25 minutes, and few survive over an hour. We would directly observe no patient for longer than one hour.
This is a straightforward study to characterize the Receiver Operator Characteristic (ROC) curves and Relative Risk of a variety of clinical data elements for predicting early death following discontinuation of life sustaining treatments. This is a multi-center study currently being conducted at: University of Cincinnati Hospital, Case-Western Reserve University Hospital and the University of Pittsburgh Medical Center with the University of Pittsburgh acting as the Coordinating Center. (a) This is a prospective cohort study of patients electively withdrawn from life sustaining treatment. The investigators and the study have no impact on the decision or timing of withdrawal of support. The study will merely record what and what time support is withdrawn, the medications that are provided for patient comfort, and the time of death. Within this group, we will determine whether patients who "meet" the UNOS criteria (UNOS cohort) have a short time to death, enabling us to validate the current, unvalidated UNOS criteria. In addition, we will analyze data from all patients, perform logistic regression to determine other candidate criteria for determining short time to death. (b) Data extractors will collect the data from all identified patients using chart review following procedures approved by their institutional review board. Data forms will be de-identified at each institution prior to transmission to our central database to ensure patient confidentiality.
The results from the project we are proposing will enable more accurate identification of appropriate candidates for NHBOD. We plan to do this by examining pre-mortem data of patients that have died after withdrawal of LST to see if any factors or combination of factors are predictive of death in less than 30 minutes and 60 minutes after LST is removed.
Our research questions are:
- Do the UNOS criteria predict early death following discontinuation of LST? 2. In addition we will collect data to enable us to address the secondary questions:
- a. What are the best predictors of early death following discontinuation of LST?, and 2.b. How accurate are they?
We intend to test the following two hypotheses:
H1: The UNOS criteria are predictive of death in less than 30 minutes; H2: The UNOS criteria are predictive of death within 60 minutes.
The researchers selected the following outcomes for the study. Outcome 1: death within 30 minutes of removal of life sustaining treatment. Outcome 2: death within 60 minutes of removal of life sustaining treatment. Outcome 3: number of potential organ donors following cardiac death
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients who have life sustaining treatments withdrawn
Key exclusion criteria (1 listed)
- confirmed brain death
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 |
|---|---|---|
| withdrawal of life sustaining treatments | Behavioural | – |
Primary outcome
Not reported in the source record.
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 31 May 2017.
Related trials for Withdrawing Treatment
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.
Michael A DeVita, MD study chair
University of Pittsburgh/University of Pittsburgh Medical Center
Christine Zowistowski, MD principal investigator
University of Tennesse, Memphis
Maria Brooks, PhD principal investigator
University of Pittsburgh
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Withdrawing Treatment, run by University of Pittsburgh at 4 sites in United States.
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 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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.
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 31 May 2017.