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

Tissue and Organ Procurement Clinical Trial

— DCDIII  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04123275
• Other study ID #: nw 2014-36
• Status: Completed
• Start date: July 7, 2015
• Est. completion date: October 2018

Study information

• Verified date: March 2019
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The main objective of this study is to determine parameters predicting time to death in potential cDCD patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Death
• Tissue and Organ Procurement

Intervention

Other:
• 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. .

Locations

Country	Name	City	State
Netherlands	Jeroen Bosch Hospital	Den Bosch
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Radboud University Medical Center	Nijmegen
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	ETZ	Tilburg
Netherlands	Isala clinics	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	36 months
Secondary	Incidence of circulatory death in 60 minutes	Number of patients with circulatory death within 60 minutes	36 months
Secondary	Incidence of circulatory death in 120 and 180 minutes	Number of patients when circulatory death occurs within the timeframe of 120 and 180 minutes	36 months
Secondary	Doses analgesia	Doses analgesia provided before and during withdrawal of life support in milligrams per hour	36 months
Secondary	Doses sedation	Doses sedation provided before and during withdrawal of life support in milligrams per hour	36 months
Secondary	Incidence of withdrawal of endotracheal tube	Number of endotracheal tubes removed	36 months