Tissue and Organ ProcurementDCDIIINCT04123275
Prediction on Time to Death in Potential Controlled Donation After Circulatory Death (cDCD) Donors (DCD III Study)
An observational study of Tissue and Organ Procurement, run by Radboud University Medical Center at 6 sites in Netherlands.
Trial summary
A considerable number of potential cDCD donors do not convert into actual organ donors because circulatory arrest does not occur within the predefined timeframe of warm ischemia after withdrawal of life-sustaining treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tissue and Organ Procurement
- How many people
- 400 participants
- Where
- 6 sitesNetherlands
- Study dates
- 7 Jul 2015to Oct 2018
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All mechanically ventilated patients admitted at the Intensive Care Unit, aged between 18 and 75 years old who are eligible to enter the organ procurement protocol of the Dutch Transplant Foundation.
Who may be able to join
- mechanically ventilated patients
- aged between 18 and 75 years old, where further treatment is futile.
- patients should meet the criteria of potential cDCD donors as defined by the Dutch Transplant Foundation
Who cannot join
- non-intubated patients
- younger than 18 years old
- brain dead patients
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites
Jeroen Bosch Hospital
's-Hertogenbosch, 5223GZ
University Medical Center Groningen
Groningen, 9713
Radboud University Medical Center
Nijmegen, 5600HB
Erasmus Medical Center
Rotterdam, 3015GD
ETZ
Tilburg, 5022GC
Isala clinics
Zwolle, 8025AB
About this study
Official title: DCD III Study: a Multicentre Prospective Study to Identify Parameters Predicting Time to Death in Controlled Circulatory Death (cDCD) Donors and Prospective Validation of Previous Derived Prediction Models on Time to Death.
A considerable number of potential cDCD donors do not convert into actual organ donors because circulatory arrest does not occur within the predefined timeframe of warm ischemia after withdrawal of life-sustaining treatment. The main objective of this study is to determine parameters predicting time to death in potential cDCD patients.
Read the detailed description
Controlled donation after circulatory death (cDCD) is a major source of organs for transplantation. Even though there is a well-established cDCD program in the Netherlands, there is still a considerable number of potential donors not being converted into actual organ donors. A potential cDCD donor poses considerable challenges in terms of a) identification of those dying within the predefined timeframe of warm ischemia, after withdrawal of life-sustaining treatment to circulatory arrest, b) managing them appropriately within the framework and resources of the intensive care unit, c) dealing with family expectations especially when failure to donation occurs, and d) efficient utilization of the organ procurement teams.
Factors associated with early circulatory collapse after treatment withdrawal include a younger age, non-triggered modes of artificial ventilation, high FiO2, the use of inotropes, and a low arterial pH. Another important factor which could influence the donor potential is end-of-life treatment. The practice of withdrawal of life support treatment (WLST) is highly variable between ICU's and countries. This influences the dying process and can thus have a large influence on the onset of cardio respiratory arrest. There is also wide variation in the use and dosage of additional sedation and analgesia during WLST and controversy exists regarding hastening or slowing down death.
Several attempts have been made to develop models to predict the time between treatment withdrawal and circulatory arrest, as this is crucial to a) proceed with organ donation, and b) the quality of the harvested organs. The selected patients however, where not always restricted to potential candidates for cDCD organ donation as patients with cancer and severe infection were also included.
Objective: Objectives of this study are: a) To determine parameters predicting time to death in potential cDCD patients b) To validate and update previous predicting models on time to death after withdrawal of life-sustaining treatment. c) To assess variation in withdrawal of life-sustaining treatment in the Netherlands and its influence on post mortal organ donor potential and actual post mortal organ donors.
Design and setting: Multicenter, observational, prospective cohort study of all potential cDCD patients of 3 university and 3 teaching hospitals in the Netherlands with diverse focus of attention
Methods: All potential cDCD patients participating in the cDCD protocol as defined by the Dutch Transplant Foundation admitted at the Intensive Care unit, will be included.
Participants: Mechanically ventilated ICU patients aged between 18 to 75 years. Brain dead patients will be excluded.
- Conditions
- Tissue and Organ Procurement
- Being tested
- No intervention wil be done. Patient characteristics and the standard care before and after withdrawal of life-sustaining treatment in all potential cDCD donors, will be studied. .
- Keywords
- Validation studies, Withholding treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention wil be done. Patient characteristics and the standard care before and after withdrawal of life-sustaining treatment in all potential cDCD donors, will be studied. .Other
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration (in minutes) on time to circulatory death after withdrawal of life-sustaining treatment, in cDCD patients
Development of a prediction tool to detect time to circulatory death (in minutes) in controlled donation after circulatory death patients (cDCD)
Measured: 36 months
Secondary outcomes (5)
Incidence of circulatory death in 60 minutes
Number of patients with circulatory death within 60 minutes
Measured: 36 months
Incidence of circulatory death in 120 and 180 minutes
Number of patients when circulatory death occurs within the timeframe of 120 and 180 minutes
Measured: 36 months
Doses analgesia
Doses analgesia provided before and during withdrawal of life support in milligrams per hour
Measured: 36 months
Doses sedation
Doses sedation provided before and during withdrawal of life support in milligrams per hour
Measured: 36 months
Incidence of withdrawal of endotracheal tube
Number of endotracheal tubes removed
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start7 Jul 2015
- Primary completion31 Aug 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tissue and Organ ProcurementStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123275
- Sponsor's protocol ID
- nw 2014-36
- Acronym
- DCDIII
- Status last verified
- Mar 2019
- First submitted
- 18 Mar 2019
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kotsopoulos A, Vos P, Witjes M, Volbeda M, Franke H, Epker J, Sonneveld H, Simons K, Bronkhorst E, Mullers R, Jansen N, van der Hoeven H, Abdo WF. Prospective Multicenter Observational Cohort Study on Time to Death in Potential Controlled Donation After Circulatory Death Donors-Development and External Validation of Prediction Models: The DCD III Study. Transplantation. 2022 Sep 1;106(9):1844-1851. doi: 10.1097/TP.0000000000004106. Epub 2022 Mar 8.
PubMed 35266926Kotsopoulos AMM, Vos P, Jansen NE, Bronkhorst EM, van der Hoeven JG, Abdo WF. Prediction Model for Timing of Death in Potential Donors After Circulatory Death (DCD III): Protocol for a Multicenter Prospective Observational Cohort Study. JMIR Res Protoc. 2020 Jun 23;9(6):e16733. doi: 10.2196/16733.
PubMed 32459638
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DCD III Study: a Multicentre Prospective Study to Identify Parameters Predicting Time to Death in Controlled Circulatory Death (cDCD) Donors and Prospective Validation of Previous Derived Prediction Models on Time to Death.
- ClinicalTrials.gov ID
- NCT04123275
- Acronym / sponsor ID
- DCDIII / nw 2014-36
- Conditions
- Tissue and Organ Procurement
- Keywords
- Validation studies, Withholding treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 7 Jul 2015 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 10 Oct 2019 (actual)
- 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.
A considerable number of potential cDCD donors do not convert into actual organ donors because circulatory arrest does not occur within the predefined timeframe of warm ischemia after withdrawal of life-sustaining treatment. The main objective of this study is to determine parameters predicting time to death in potential cDCD patients.
Detailed description
Controlled donation after circulatory death (cDCD) is a major source of organs for transplantation. Even though there is a well-established cDCD program in the Netherlands, there is still a considerable number of potential donors not being converted into actual organ donors. A potential cDCD donor poses considerable challenges in terms of a) identification of those dying within the predefined timeframe of warm ischemia, after withdrawal of life-sustaining treatment to circulatory arrest, b) managing them appropriately within the framework and resources of the intensive care unit, c) dealing with family expectations especially when failure to donation occurs, and d) efficient utilization of the organ procurement teams.
Factors associated with early circulatory collapse after treatment withdrawal include a younger age, non-triggered modes of artificial ventilation, high FiO2, the use of inotropes, and a low arterial pH. Another important factor which could influence the donor potential is end-of-life treatment. The practice of withdrawal of life support treatment (WLST) is highly variable between ICU's and countries. This influences the dying process and can thus have a large influence on the onset of cardio respiratory arrest. There is also wide variation in the use and dosage of additional sedation and analgesia during WLST and controversy exists regarding hastening or slowing down death.
Several attempts have been made to develop models to predict the time between treatment withdrawal and circulatory arrest, as this is crucial to a) proceed with organ donation, and b) the quality of the harvested organs. The selected patients however, where not always restricted to potential candidates for cDCD organ donation as patients with cancer and severe infection were also included.
Objective: Objectives of this study are: a) To determine parameters predicting time to death in potential cDCD patients b) To validate and update previous predicting models on time to death after withdrawal of life-sustaining treatment. c) To assess variation in withdrawal of life-sustaining treatment in the Netherlands and its influence on post mortal organ donor potential and actual post mortal organ donors.
Design and setting: Multicenter, observational, prospective cohort study of all potential cDCD patients of 3 university and 3 teaching hospitals in the Netherlands with diverse focus of attention
Methods: All potential cDCD patients participating in the cDCD protocol as defined by the Dutch Transplant Foundation admitted at the Intensive Care unit, will be included.
Participants: Mechanically ventilated ICU patients aged between 18 to 75 years. Brain dead patients will be excluded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All mechanically ventilated patients admitted at the Intensive Care Unit, aged between 18 and 75 years old who are eligible to enter the organ procurement protocol of the Dutch Transplant Foundation.
Key inclusion criteria (3 listed)
- mechanically ventilated patients
- aged between 18 and 75 years old, where further treatment is futile.
- patients should meet the criteria of potential cDCD donors as defined by the Dutch Transplant Foundation
Key exclusion criteria (3 listed)
- non-intubated patients
- younger than 18 years old
- brain dead patients
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 |
|---|---|---|
| No intervention wil be done. Patient characteristics and the standard care before and after withdrawal of life-sustaining treatment in all potential cDCD donors, will be studied. . | Other | – |
Primary outcome
Duration (in minutes) on time to circulatory death after withdrawal of life-sustaining treatment, in cDCD patients
Time frame: 36 months
Development of a prediction tool to detect time to circulatory death (in minutes) in controlled donation after circulatory death patients (cDCD)
5 secondary outcomes
Incidence of circulatory death in 60 minutes
Time frame: 36 months
Incidence of circulatory death in 120 and 180 minutes
Time frame: 36 months
Doses analgesia
Time frame: 36 months
Doses sedation
Time frame: 36 months
Incidence of withdrawal of endotracheal tube
Time frame: 36 months
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 10 Oct 2019.
- Derived from this study: PubMed 35266926Kotsopoulos A, Vos P, Witjes M, Volbeda M, Franke H, Epker J, Sonneveld H, Simons K, Bronkhorst E, Mullers R, Jansen N, van der Hoeven H, Abdo WF. Prospective Multicenter Observational Cohort Study on Time to Death in Potential Controlled Donation After Circulatory Death Donors-Development and External Validation of Prediction Models: The DCD III Study. Transplantation. 2022 Sep 1;106(9):1844-1851. doi: 10.1097/TP.0000000000004106. Epub 2022 Mar 8.
- Derived from this study: PubMed 32459638Kotsopoulos AMM, Vos P, Jansen NE, Bronkhorst EM, van der Hoeven JG, Abdo WF. Prediction Model for Timing of Death in Potential Donors After Circulatory Death (DCD III): Protocol for a Multicenter Prospective Observational Cohort Study. JMIR Res Protoc. 2020 Jun 23;9(6):e16733. doi: 10.2196/16733.
- Individual participant dataSharing planned: No
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tissue and Organ Procurement, run by Radboud University Medical Center at 6 sites in Netherlands.
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 3 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 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. 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?
Duration (in minutes) on time to circulatory death after withdrawal of life-sustaining treatment, in cDCD patients (time frame: 36 months). 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 NCT04123275, which also lists 2 linked publications.
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 10 Oct 2019.