Prediction model for timing of death in potential donors after circulatory death (DCD III): study protocol for a multicenter, prospective, observational, cohort study.

BACKGROUND: Controlled donation after circulatory death (cDCD) is a major source of organs for transplantation. A potential cDCD donor poses considerable challenges in terms of identification of those dying within the predefined timeframe of warm ischemia after withdrawal of life-sustaining treatment (WLST) to circulatory arrest. Several attempts have been made to develop models predicting the time between treatment withdrawal and circulatory arrest. This time window determines whether organ donation can occur and influences the quality of the donated organs. However, the selected patients used for these models, where not always restricted to potential cDCD donors, e.g. patients with cancer or severe infections were also included. This severely limits the generalizability of those data.
OBJECTIVE: Objectives of this study are: (1) To develop a model predicting time to death within 60 minutes in potential cDCD patients; (2) To validate and update previous prediction models on time to death after WLST; (3) To determine timing and patient characteristics that are associated with prognostication and the decision-making process that leads to initiating end-of-life care; (4) To evaluate the impact of timing of family approach for organ donation approval; (5) To assess the influence of (variation in) WLST on post mortal organ donor potential and actual post mortal organ donors.
METHODS: In this multicentre, observational, prospective cohort study, all patients admitted at the Intensive Care unit, of three university and three teaching hospitals, meeting the criteria of the cDCD protocol as defined by the Dutch Transplant Foundation, are included. The target of enrolment is set on 400 patients. Previous developed models will be refitted in our data set. To further update previous prediction models, we will apply LASSO as a tool for efficient variable selection for the multivariable logistic regression model to be developed.
RESULTS: This protocol was funded in August 2014 by The Dutch Transplant Foundation. The results of the study will be expected in July 2020. Patient enrolment was completed in July 2018 and data collection will be completed in April 2020.
CONCLUSIONS: This study will provide a robust multimodal prediction model based on clinical and physiological parameters, which can predict time to circulatory arrest in cDCD donors. In addition, it will add valuable insight in the process of WLST in cDCD donors and as such will fill an important knowledge gap in this essential field of healthcare. CLINICALTRIAL: ClinicalTrials.gov NCT04123275; https://clinicaltrials.gov/ct2/show/NCT04123275.