Ignite Creation Date:
2024-05-06 @ 1:48 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04123275
Status:
COMPLETED
Last Update Posted:
2019-10-10
First Post:
2019-03-18
Brief Title:
Prediction on Time to Death in Potential Controlled Donation After Circulatory Death cDCD Donors DCD III Study
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DCDIII
Brief 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 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 ICUs 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
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 ICUs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None