Tissue and Organ ProcurementNCT02430961
Predictors of Apnea and Prediction of Time to Death in Donation After Cardiac Death
An observational study of Tissue and Organ Procurement, run by University Health Network, Toronto.
Trial summary
Donation after Cardiac Death (DCD) is an increasingly common mechanism through wish patients can donate tissue and organs following death after withdrawal of life sustaining therapies (WLST). Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Tissue and Organ Procurement
- How many people
- 158 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to May 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We will include all patients who are deemed eligible for DCD by Trillium Gift of Life Network (TGLN) and in whom informed consent for DCD is obtained from the substitute decision maker. All patients will be included in the study if they undergo withdrawal of life sustaining therapy for the potential of donation (whether they successfully donate or not). Any patient on mechanical ventilation who is 80 years of age or under is a potential DCD candidate if there is a plan for elective WLST.
Who may be able to join
- Planned withdrawal of life sustaining therapy
- Deemed eligible for DCD by Trillium Gift of Life
- Signed consent for DCD following withdrawal of life sustaining therapy
Who cannot join
- Refusal to or withdrawal of consent to DCD
- Patients in whom organs are deemed unsuitable for donation prior to withdrawal of life sustaining therapy
Trial locations and contacts
No sites are listed yet.
About this study
Donation after Cardiac Death (DCD) is an increasingly common mechanism through wish patients can donate tissue and organs following death after withdrawal of life sustaining therapies (WLST). Unfortunately many potential DCD donors are not ultimately able to donate and this is a significant emotional and resource burden to families, healthcare workers and hospitals. A tool that allows accurate prediction of time to death following WLST (and thus the probability of successful donation) is urgently needed. Existing models have not been useful due to the lack of generalizability. Additionally, existing models have not included other important factors now recognized to be associated with time to death following WLST.
The investigators will conduct a prospective, observational cohort study of all patients being considered for DCD in whom consent for donation is obtained to evaluate the association between neurologic and non-neurologic risk factors for apnea, other clinically important variables and time to death after WLST, and use these data to derive a generalizable predictive model for the prediction of the time to death following WLST in potential DCD donors.
Read the detailed description
Donation after cardiac death (DCD) is a method by which patients have the opportunity to donate organs following elective withdrawal of life-sustaining therapies (WLST). Often these patients have suffered a catastrophic neurological injury although not progressed to brain death or have a severe medical condition for which ongoing medical care is considered non-beneficial. DCD has become an increasingly significant source of organs for transplantation in a time of growing wait lists and organ shortfall.
In order to donate organs through DCD, the potential donor must progress to death within a certain time window after withdrawal of life sustaining therapies. This timeframe varied but is usually less than 120 minutes following WLST. Up to 40% of potentially eligible DCD donors in Ontario do not proceed to organ procurement for these reasons (internal data from Trillium Gift of Life).
The uncertainty and variability in the potential for successful organ procurement has an impact on families, health care teams and organ retrieval teams. It is important that this emotional and resource burden only occurs in candidates with a reasonable likelihood of being eligible to donate organs. The amount of time elapsing between WLST and circulatory arrest (and organ procurement) has important implications for the quality of the procured organs, and some organs are unable to be transplanted after death. Finally, maintaining organ procurement teams and an operating room on standby consumes valuable hospital resources and removes these human and physical resources from other clinical duties.
Several different prediction tools have been proposed to predict time to death following WLST in potential DCD donors, but none has been proven useful. To derive a more generalizable prediction tool it is necessary to identify valid predictors that are common to a wide variety of patients undergoing WLST. We propose the addition of features that predict apnea or respiratory insufficiency in the development of a new predictive model.
While previous studies propose important variables for prediction of time to death, we hypothesize that features that are focused on apnea (neurologic and non-neurologic) will be independently predictive of time of death following WLST.
Neurological predictors of apnea: The previous studies have consistently identified one or two neurologic risk factors for apnea associated with time to death. These risk factors have been evaluated in isolation and have never been rigorously studied in a broader population or in combination. We wish to evaluate the following neurological risk factors for apnea which have been previously found to be associated with time to death in certain studies: Glasgow Coma Scale, absence of brain stem reflexes (corneal, pupil, cough, gag), and controlled mode of mechanical ventilation.
Non-Neurological predictors of apnea: No studies to date have evaluated features focused on non-neurologic causes of apnea. Given that neurologic predictors of apnea have been the one consistent feature that has been identified across most studies, we hypothesize that evaluating additional predictors of apnea beyond neurologic causes could similarly have an association with time to death as they both result in profound hypoxia. While some researchers have evaluated the contribution of BMI and weight, we hypothesize that the addition of more definitive features of upper airway obstruction will strengthen the performance of our prediction tool. Neck circumference, absence of endotracheal tube cuff leak, fluid balance, and history of obstructive sleep apnea (OSA) are novel and could improve the operating characteristics of prediction tools.
Neck circumference has been found to be associated with airway obstruction and has been incorporated into numerous prediction tools for OSA. In a study evaluating prevalence and predictors of upper airway obstruction following stroke, neck circumference was independently associated with any upper airway obstruction that occurred 24 hours following acute stroke. In a pooled analysis, the absence of cuff leak has been shown to be predictive of post extubation stridor with 92% specificity, thus suggesting impending loss of airway patency. Fluid balance has also been found to be associated with post extubation failure.
We will conduct a prospective, observational cohort study of all patients being considered for DCD in whom consent for donation is obtained to evaluate the association between neurologic and non-neurologic risk factors for apnea, other clinically important variables and time to death after WLST, and use these data to derive a generalizable predictive model for the prediction of the time to death following WLST in potential DCD donors.
- Conditions
- Tissue and Organ Procurement
- Keywords
- Critical Care, Palliative Care
What is being measured
The primary outcome is the main question the study is designed to answer.
Death (at 120 minutes)
The primary outcome is death within 120 minutes of WLST. Time to death is defined as the period from the initiation of withdrawal of life supportive therapies and the declaration of death (inclusive of waiting period following circulatory arrest).
Measured: 120 minutes following withdrawal of life sustaining therapy
Secondary outcomes (4)
Death (at 60 minutes)
Death within 60 minutes of WLST is a secondary outcome. Time to death is defined as the period from the initiation of withdrawal of life supportive therapies and the declaration of death (inclusive of waiting period following circulatory arrest).
Measured: 60 minutes following withdrawal of life sustaining therapy
Death (at 30 minutes)
Death within 30 minutes of WLST is a secondary outcome. Time to death is defined as the period from the initiation of withdrawal of life supportive therapies and the declaration of death (inclusive of waiting period following circulatory arrest).
Measured: 30 minutes following withdrawal of life sustaining therapy
Warm Ischemic Time
Measured: 120 minutes following withdrawal of life sustaining therapy
Number and Type of Organs procured
Measured: 24 hours following withdrawal of life sustaining therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue and Organ ProcurementStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Prospective
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Trillium Gift of Life Network, Ontario, The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, Jeffrey M Singh, MD, University Health Network, Toronto
- Investigators
- Jeffrey M Singh, MD, Principal investigator, University of Toronto / University Health NetworkLaveena Munshi, MD, Principal investigator, University of Toronto / University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430961
- Sponsor's protocol ID
- UHN 15-9107
- Status last verified
- Apr 2015
- First submitted
- 27 Apr 2015
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Apnea and Prediction of Time to Death in Donation After Cardiac Death
- ClinicalTrials.gov ID
- NCT02430961
- Acronym / sponsor ID
- UHN 15-9107
- Conditions
- Tissue and Organ Procurement
- Keywords
- Critical Care, Palliative Care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Trillium Gift of Life Network, Ontario, The Physicians' Services Incorporated Foundation
- Study start
- Jun 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 30 Apr 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.
Donation after Cardiac Death (DCD) is an increasingly common mechanism through wish patients can donate tissue and organs following death after withdrawal of life sustaining therapies (WLST). Unfortunately many potential DCD donors are not ultimately able to donate and this is a significant emotional and resource burden to families, healthcare workers and hospitals. A tool that allows accurate prediction of time to death following WLST (and thus the probability of successful donation) is urgently needed. Existing models have not been useful due to the lack of generalizability. Additionally, existing models have not included other important factors now recognized to be associated with time to death following WLST.
The investigators will conduct a prospective, observational cohort study of all patients being considered for DCD in whom consent for donation is obtained to evaluate the association between neurologic and non-neurologic risk factors for apnea, other clinically important variables and time to death after WLST, and use these data to derive a generalizable predictive model for the prediction of the time to death following WLST in potential DCD donors.
Detailed description
Donation after cardiac death (DCD) is a method by which patients have the opportunity to donate organs following elective withdrawal of life-sustaining therapies (WLST). Often these patients have suffered a catastrophic neurological injury although not progressed to brain death or have a severe medical condition for which ongoing medical care is considered non-beneficial. DCD has become an increasingly significant source of organs for transplantation in a time of growing wait lists and organ shortfall.
In order to donate organs through DCD, the potential donor must progress to death within a certain time window after withdrawal of life sustaining therapies. This timeframe varied but is usually less than 120 minutes following WLST. Up to 40% of potentially eligible DCD donors in Ontario do not proceed to organ procurement for these reasons (internal data from Trillium Gift of Life).
The uncertainty and variability in the potential for successful organ procurement has an impact on families, health care teams and organ retrieval teams. It is important that this emotional and resource burden only occurs in candidates with a reasonable likelihood of being eligible to donate organs. The amount of time elapsing between WLST and circulatory arrest (and organ procurement) has important implications for the quality of the procured organs, and some organs are unable to be transplanted after death. Finally, maintaining organ procurement teams and an operating room on standby consumes valuable hospital resources and removes these human and physical resources from other clinical duties.
Several different prediction tools have been proposed to predict time to death following WLST in potential DCD donors, but none has been proven useful. To derive a more generalizable prediction tool it is necessary to identify valid predictors that are common to a wide variety of patients undergoing WLST. We propose the addition of features that predict apnea or respiratory insufficiency in the development of a new predictive model.
While previous studies propose important variables for prediction of time to death, we hypothesize that features that are focused on apnea (neurologic and non-neurologic) will be independently predictive of time of death following WLST.
Neurological predictors of apnea: The previous studies have consistently identified one or two neurologic risk factors for apnea associated with time to death. These risk factors have been evaluated in isolation and have never been rigorously studied in a broader population or in combination. We wish to evaluate the following neurological risk factors for apnea which have been previously found to be associated with time to death in certain studies: Glasgow Coma Scale, absence of brain stem reflexes (corneal, pupil, cough, gag), and controlled mode of mechanical ventilation.
Non-Neurological predictors of apnea: No studies to date have evaluated features focused on non-neurologic causes of apnea. Given that neurologic predictors of apnea have been the one consistent feature that has been identified across most studies, we hypothesize that evaluating additional predictors of apnea beyond neurologic causes could similarly have an association with time to death as they both result in profound hypoxia. While some researchers have evaluated the contribution of BMI and weight, we hypothesize that the addition of more definitive features of upper airway obstruction will strengthen the performance of our prediction tool. Neck circumference, absence of endotracheal tube cuff leak, fluid balance, and history of obstructive sleep apnea (OSA) are novel and could improve the operating characteristics of prediction tools.
Neck circumference has been found to be associated with airway obstruction and has been incorporated into numerous prediction tools for OSA. In a study evaluating prevalence and predictors of upper airway obstruction following stroke, neck circumference was independently associated with any upper airway obstruction that occurred 24 hours following acute stroke. In a pooled analysis, the absence of cuff leak has been shown to be predictive of post extubation stridor with 92% specificity, thus suggesting impending loss of airway patency. Fluid balance has also been found to be associated with post extubation failure.
We will conduct a prospective, observational cohort study of all patients being considered for DCD in whom consent for donation is obtained to evaluate the association between neurologic and non-neurologic risk factors for apnea, other clinically important variables and time to death after WLST, and use these data to derive a generalizable predictive model for the prediction of the time to death following WLST in potential DCD donors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We will include all patients who are deemed eligible for DCD by Trillium Gift of Life Network (TGLN) and in whom informed consent for DCD is obtained from the substitute decision maker. All patients will be included in the study if they undergo withdrawal of life sustaining therapy for the potential of donation (whether they successfully donate or not). Any patient on mechanical ventilation who is 80 years of age or under is a potential DCD candidate if there is a plan for elective WLST.
Key inclusion criteria (3 listed)
- Planned withdrawal of life sustaining therapy
- Deemed eligible for DCD by Trillium Gift of Life
- Signed consent for DCD following withdrawal of life sustaining therapy
Key exclusion criteria (2 listed)
- Refusal to or withdrawal of consent to DCD
- Patients in whom organs are deemed unsuitable for donation prior to withdrawal of life sustaining therapy
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
Death (at 120 minutes)
Time frame: 120 minutes following withdrawal of life sustaining therapy
The primary outcome is death within 120 minutes of WLST. Time to death is defined as the period from the initiation of withdrawal of life supportive therapies and the declaration of death (inclusive of waiting period following circulatory arrest).
4 secondary outcomes
Death (at 60 minutes)
Time frame: 60 minutes following withdrawal of life sustaining therapy
Death (at 30 minutes)
Time frame: 30 minutes following withdrawal of life sustaining therapy
Warm Ischemic Time
Time frame: 120 minutes following withdrawal of life sustaining therapy
Number and Type of Organs procured
Time frame: 24 hours following withdrawal of life sustaining therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 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.
Jeffrey M Singh, MD principal investigator
University of Toronto / University Health Network
Laveena Munshi, MD principal investigator
University of Toronto / University Health Network
Questions about this trial
What is this clinical trial studying?
An observational study of Tissue and Organ Procurement, run by University Health Network, Toronto.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 30 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey M Singh, MD (416-603-5800 ext. 3221, jeff.singh@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (at 120 minutes) (time frame: 120 minutes following withdrawal of life sustaining therapy). 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 30 Apr 2015.