Conducting Multi-Centre, International, Observational Studies During the End-of-Life in Intensive Care - Setting up and Managing the DePPaRT Study
CCCF ePoster library. van Beinum A. Oct 31, 2016; 150914; 35
Amanda van Beinum
Amanda van Beinum
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Topic: Retrospective or Prospective Cohort Study

Conducting Multi-Centre, International, Observational Studies During the End-of-Life in Intensive Care – Setting up and Managing the DePPaRT Study


van Beinum, Amanda1; Hornby, Laura2; Scales, Nathan3; Dhanani, Sonny4
1
Children's Hospital of Eastern Ontario Research Institute, Ottawa, Canada; 2Bertram Loeb Research Consortium in Organ and Tissue Donation, University of Ottawa, Ottawa, Canada; 3Dynamical Analysis Laboratory, Ottawa Hospital Research Institute, Ottawa, Canada; 4Children's Hospital of Eastern Ontario, Ottawa, Canada


Grant acknowledgements:
The DePPaRT study is funded by the Canadian Institutes of Health Research (CIHR) through the Canadian National Transplant Research Network (CNTRP).

Abstract:

Introduction: Organ donation after circulatory determination of death (DCD) represents an important source of transplantable organs1, but uptake of DCD programs is hindered in part by the lack of evidence-based guidelines2. The Death Prediction and Physiology after Removal of Therapy (DePPaRT) study was envisioned as a prospective, observational, multi-center study to gather the required robust data on the natural history of death following withdrawal of life sustaining therapies in intensive care units. Collection of multi-center, prospective observational data on imminently dying and recently dead patients, including both potential and actual DCD organ donors, represents a novel undertaking in critical care research. The DePPaRT study has faced unique challenges and created new opportunities for research in deceased organ donation.
 
Objectives: To describe the design and implementation of the DePPaRT study, along with a careful recollecting of unique challenges and opportunities uncovered by novel research in an imminently dying and recently dead population.
 
Methods: In 2014 the Canadian National Transplant Research Network3 granted the DePPaRT study funding for enrollment of 500 patients and support of a central coordinating site for 2 years. The DePPaRT study planned to use a combination of clinical data collection and real-time download of physiologic monitor data in patients where a decision to withdraw life sustaining therapy had been made and the family had provided first person consent for research. Patients are monitored continuously from 15 minutes prior to withdrawal of life sustaining therapies until 30 minutes following the declaration of death. 14 Canadian intensive care units were initially selected as study sites.
 
Results: As of summer 2016, the DePPaRT study is actively enrolling patients at 13 sites in Canada (1 pediatric, 12 adult), and 3 international sites in Prague, Czech Republic. A total of 235 out of 500 patients have been enrolled, including 123 from Prague, with an overall consent rate of 94%. Challenges encountered by the DePPaRT study have included: administrative delays with funding and contracts, personnel issues, physiologic waveform collection issues, resistance from local site teams regarding the approach of families of dying patients, and data management concerns. Opportunities identified by this study so far include: an abundance of interest in the study by national and international collaborators, buy-in from patient partners, positive response from bedside care teams, and positive experiences with hospital ethics boards.
 
Conclusions: Despite conducting research in a vulnerable population of imminently dying and recently dead patients, we have had strong participation in this study and wide-spread engagement across Canada and internationally. Major challenges have included administrative study management concerns rather than ethical or moral hurdles. Prospective observational research in imminently dying and recently dead populations is possible, and it is possible on a scale large enough to help answer pressing questions in the practice of deceased organ donation.


References:

1. Hernadez-Alejandro, R. et al. Organ donation after cardiac death: Donor and recipient outcomes after the first three years of the Ontario experience. Can J Anaesth 58, 599–605 (2011).
2. Weiss, M. J., Hornby, L., Witteman, W. & Shemie, S. D. Pediatric Donation After Circulatory Determination of Death: A scoping review. Pediatr. Crit. Care Med. 17, e87–e108 (2016).
3. Hébert, M.-J., Hartell, D. & West, L. Transdisciplinary tour-de-force. Transplantation 100, 466–470 (2016).
 



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