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.

Prediction on Time to Death in Potential Controlled Donation After Circulatory Death (cDCD) Donors (DCD III Study)

Sponsors

Lead sponsor: Radboud University

Source Radboud University
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 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.

Overall Status Completed
Start Date July 7, 2015
Completion Date October 2018
Primary Completion Date August 31, 2018
Study Type Observational
Primary Outcome
Measure Time Frame
Duration (in minutes) on time to circulatory death after withdrawal of life-sustaining treatment, in cDCD patients 36 months
Secondary Outcome
Measure Time Frame
Incidence of circulatory death in 60 minutes 36 months
Incidence of circulatory death in 120 and 180 minutes 36 months
Doses analgesia 36 months
Doses sedation 36 months
Incidence of withdrawal of endotracheal tube 36 months
Enrollment 400
Condition
Intervention

Intervention type: Other

Intervention name: 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. .

Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- non-intubated patients

- younger than 18 years old

- brain dead patients

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Location
facility
Jeroen Bosch Hospital | Den Bosch, 5223GZ, Netherlands
University Medical Center Groningen | Groningen, 9713, Netherlands
Radboud University Medical Center | Nijmegen, 5600HB, Netherlands
Erasmus Medical Center | Rotterdam, 3015GD, Netherlands
ETZ | Tilburg, 5022GC, Netherlands
Isala clinics | Zwolle, 8025AB, Netherlands
Location Countries

Netherlands

Verification Date

March 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Acronym DCDIII
Patient Data No
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov