Sonny Dhanani

An Official American Thoracic Society/International Society for Heart and Lung Transplantation/Society of Critical Care Medicine/Association of Organ and Procurement Organizations/United Network of Organ Sharing Statement: Ethical and Policy Considerations in Organ Donation after Circulatory Determination of Death

RATIONALE Donation after circulatory determination of death (DCDD) has the potential to increase the number of organs available for transplantation. Because consent and management of potential donors must occur before death, DCDD raises unique ethical and policy issues. OBJECTIVES To develop an ethics and health policy statement on adult and pediatric DCDD relevant to critical care and transplantation stakeholders. METHODS A multidisciplinary panel of stakeholders was convened to develop an ethics and health policy statement. The panel consisted of representatives from the American Thoracic Society, Society of Critical Care Medicine, International Society for Heart and Lung Transplantation, Association of Organ Procurement Organizations, and the United Network of Organ Sharing. The panel reviewed the literature, discussed important ethics and health policy considerations, and developed a guiding framework for decision making by stakeholders. RESULTS A framework to guide ethics and health policy statement was established, which addressed the consent process, pre- and post mortem interventions, the determination of death, provisions of end-of-life care, and pediatric DCDD. CONCLUSIONS The information presented in this Statement is based on the current evidence, experience, and clinical rationale. New clinical research and the development and dissemination of new technologies will eventually necessitate an update of this Statement.

Variability in the determination of death after cardiac arrest: a review of guidelines and statements.

Introduction: The reemergence of organ donation after circulatory determination of death (DCDD) in Canada demands the establishment of clear, evidence-based guidelines for the determination of death. The primary purpose of this study was to investigate the variability in specific criteria, diagnostic tests, and recommended wait periods for the determination of death after cardiac arrest. Methods: We used PubMed and Web of Science to perform a structured search of the medical literature for articles published up to January 1, 2010. We also performed an unstructured search of the internet for unrestricted, readily available, nonjournal sources. We limited the search to countries that are most active in DCDD. Results: A total of 26 documents were retrieved; 21 medical professional society/institution statements and 5 national/international guidelines. Specific criteria for the determination of death after cardiac arrest were cited in 24 documents: 14 recommend cardiocirculatory criteria alone; 6 oblige the requirement of a prolonged waiting period after declaration to ensure neurological death; 3 recommend following “accepted medical practice” without specific details; and 1 leaves the definition up to “national authorities.” Only 16 of the documents require specific diagnostic procedures with unresponsiveness, absent arterial pulse and apnea cited the most consistently. Specific wait periods after declaration are required for the determination of death after cardiac arrest in 24 documents, cited times range from 2 to 10 minutes, with a 5-minute period the most frequent. Conclusions: This review is the first to document the variability of guidelines and statements for the determination of death after cardiac arrest, in countries where the practice of DCDD is becoming increasingly common. The scarcity of peer-reviewed published guidelines in the medical literature exemplifies the need for further investigation. We believe these results will inform the ethical discussions surrounding the determination of death after cardiac arrest. Clear and consistent guidelines based on evidence are needed to fulfill medical, ethical, and legal obligation and to ensure public trust.

Survey of determination of death after cardiac arrest by intensive care physicians.

Objective: The controversy regarding death determination in the context of organ donation after cardiocirculatory death requires investigation. We sought to describe the manner in which Canadian adult and pediatric intensive care physicians report death determination after cardiac arrest. Design: Pilot-tested paper survey. Setting: Mail out between June and November 2009. Subjects: Canadian adult and pediatric intensive care physicians. Intervention: Paper-based survey. Main Results: Forty-nine percent of 501 Canadian intensive care physicians responded. Eighty-five percent practiced in tertiary care, university-affiliated centers, and 26% were from pediatric centers. Physicians had a median of 10 yrs (range 0–35) experience. Physicians reported that they performed determination of death after cardiac arrest a median of seven (range 0–60) times per year. Of 11 tests or procedures used, the absence of heart sounds by auscultation, palpable pulse, and breath sounds were the most common, although there was high variability in practice. No diagnostic test/procedure was uniformly performed or omitted. Sixty-five percent of respondents believed autoresuscitation exists and 37% of physicians reported to have seen a possible case during their career. Forty-eight percent had formal training for determining death after cardiac arrest and 22% used guidelines. The majority of respondents agreed that standardized methods for determination of death after cardiac arrest are required in general (69%) and specifically for donation after cardiocirculatory death (91%). Conclusions: Intensive care physicians in Canada report: 1) variability in the practice of determining death after cardiac arrest; 2) the existence of autoresuscitation; and 3) a need for standardization of practice. The results of this survey support the need to develop more robust education, guidelines, and standards for the determination of death after cardiac arrest, in general, as well as within the context of donation after cardiocirculatory death.

Intra- and inter-observer reliability using a noninvasive ultrasound cardiac output monitor in healthy anesthetized children

Background:  Accurate and reliable evaluation of cardiac index (CI) in critically ill pediatric patients can optimize their management. Although validated, noninvasive ultrasound measurement techniques have been previously shown to be unreliable because of observer variability.

Advancing the science of organ donor management

There is an increasing burden of responsibility for intensivists to optimize donation potential after the declaration of brain death in patients with catastrophic brain injury. Best practice for donor management, if present, has been formed on low quality and mainly observational studies or consensus. In particular, research into the use of corticosteroids has shown varied benefit. The specific and limited results of the CORTICOME study are less important than the systematic methodology and the development of rigour in the study of deceased organ donation. Donor management would benefit from continued systematic analysis of current literature, understanding of the physiologic basis for therapy, and further prospective controlled trials. Worldwide collaboration partnerships and funding are needed to optimize the management of deceased organ donation.

Canadian Guidelines for Controlled Pediatric Donation After Circulatory Determination of Death—summary Report*

Objectives: Create trustworthy, rigorous, national clinical practice guidelines for the practice of pediatric donation after circulatory determination of death in Canada. Methods: We followed a process of clinical practice guideline development based on World Health Organization and Canadian Medical Association methods. This included application of Grading of Recommendations Assessment, Development, and Evaluation methodology. Questions requiring recommendations were generated based on 1) 2006 Canadian donation after circulatory determination of death guidelines (not pediatric specific), 2) a multidisciplinary symposium of national and international pediatric donation after circulatory determination of death leaders, and 3) a scoping review of the pediatric donation after circulatory determination of death literature. Input from these sources drove drafting of actionable questions and Good Practice Statements, as defined by the Grading of Recommendations Assessment, Development, and Evaluation group. We performed additional literature reviews for all actionable questions. Evidence was assessed for quality using Grading of Recommendations Assessment, Development, and Evaluation and then formulated into evidence profiles that informed recommendations through the evidence-to-decision framework. Recommendations were revised through consensus among members of seven topic-specific working groups and finalized during meetings of working group leads and the planning committee. External review was provided by pediatric, critical care, and critical care nursing professional societies and patient partners. Results: We generated 63 Good Practice Statements and seven Grading of Recommendations Assessment, Development, and Evaluation recommendations covering 1) ethics, consent, and withdrawal of life-sustaining therapy, 2) eligibility, 3) withdrawal of life-sustaining therapy practices, 4) ante and postmortem interventions, 5) death determination, 6) neonatal pediatric donation after circulatory determination of death, 7) cardiac and innovative pediatric donation after circulatory determination of death, and 8) implementation. For brevity, 48 Good Practice Statement and truncated justification are included in this summary report. The remaining recommendations, detailed methodology, full Grading of Recommendations Assessment, Development, and Evaluation tables, and expanded justifications are available in the full text report. Conclusions: This process showed that rigorous, transparent clinical practice guideline development is possible in the domain of pediatric deceased donation. Application of these recommendations will increase access to pediatric donation after circulatory determination of death across Canada and may serve as a model for future clinical practice guideline development in deceased donation.

Electroencephalographic Recordings During Withdrawal of Life-Sustaining Therapy Until 30 Minutes After Declaration of Death

BACKGROUND The timing of the circulatory determination of death for organ donation presents a medical and ethical challenge. Concerns have been raised about the timing of electrocerebral inactivity in relation to the cessation of circulatory function in organ donation after cardio-circulatory death. Nonprocessed electroencephalographic (EEG) measures have not been characterized and may provide insight into neurological function during this process. METHODS We assessed electrocortical data in relation to cardiac function after withdrawal of life-sustaining therapy and in the postmortem period after cardiac arrest for four patients in a Canadian intensive care unit. Subhairline EEG and cardio-circulatory monitoring including electrocardiogram, arterial blood pressure (ABP), and oxygen saturation were captured. RESULTS Electrocerebral inactivity preceded the cessation of the cardiac rhythm and ABP in three patients. In one patient, single delta wave bursts persisted following the cessation of both the cardiac rhythm and ABP. There was a significant difference in EEG amplitude between the 30-minute period before and the 5-minute period following ABP cessation for the group, but we did not observe any well-defined EEG states following the early cardiac arrest period. CONCLUSIONS In a case series of four patients, EEG inactivity preceded electrocardiogram and ABP inactivity during the dying process in three patients. Further study of the electroencephalogram during the withdrawal of life sustaining therapies will add clarity to medical, ethical, and legal concerns for donation after circulatory determined death.

Frequency, Composition, and Predictors of In-transit Critical Events During Pediatric Critical Care Transport*

Objectives: Transport of pediatric patients is common due to healthcare regionalization. We set out to determine the frequency of in-transit critical events during pediatric critical care transport and identify factors associated with these events. Design: Retrospective cohort study using administrative and clinical data. Setting: Single pediatric critical care transport provider in Ontario, Canada. Patients: All pediatric care transports between January 1, 2005, and December 31, 2010. Measurements and Main Results: The primary outcome was in-transit critical events, defined by an adaptation of a recent consensus definition. In-transit critical events occurred in 1,094 (12.3%) of 8,889 transports. Hypotension (3.6%), tachycardia (3.7%), and bradycardia (3.3%) were the most common critical events. Crews performed medical interventions in 194 transports (2.2%). The frequency and makeup of critical events varied across patient age groups. Age, pretransport mechanical ventilation, pretransport cardiovascular instability, transport duration, scene calls, and paramedic crew level were independently associated with increased risk of in-transit critical events in multivariate analysis. A Transport Pediatric Early Warning Score of 7 or greater predicted in-transit critical events with high specificity but low sensitivity (92.0% and 20.0%, respectively), but was not superior of the combination of pretransport mechanical ventilation and pretransport cardiovascular instability (sensitivity and specificity of 12.6% and 97.4%, respectively). Removal of early warning signs from the definition resulted in critical event rates comparable to those published in adults and improved predictive performance. Conclusions: Using new consensus definitions of transport-related critical events, we found critical events occurred in almost one in eight transports, and were strongly associated with pretransport cardiovascular instability. Transport Pediatric Early Warning Score was poorly predictive of in-transit critical events, and was not superior to the presence of pretransport mechanical ventilation and cardiovascular instability. Future prospective studies are required to elucidate the optimal matching of transport resources to patients, in particular those with both pretransport cardiovascular instability and mechanical ventilation.

Ethics Guide Recommendations for Organ-donation-focused Physicians: Endorsed by the Canadian Medical Association.

Donation physicians are specialists with expertise in organ and tissue donation and have been recognized internationally as a key contributor to improving organ and tissue donation services. Subsequent to a 2011 Canadian Critical Care Society-Canadian Blood Services consultation, the donation physician role has been gradually implemented in Canada. These professionals are generally intensive care unit physicians with an enhanced focus and expertise in organ/tissue donation. They must manage the dual obligation of caring for dying patients and their families while providing and/or improving organ donation services. In anticipation of actual, potential or perceived ethical challenges with the role, Canadian Blood Services in partnership with the Canadian Medical Association organized the development of an evidence-informed consensus process of donation experts and bioethicists to produce an ethics guide. This guide includes overarching principles and benefits of the DP role, and recommendations in regard to communication with families, role disclosure, consent discussions, interprofessional conflicts, conscientious objection, death determination, donation specific clinical practices in neurological determination of death and donation after circulatory death, end-of-life care, performance metrics, resources and remuneration. Although this report is intended to inform donation physician practices, it is recognized that the recommendations may have applicability to other professionals (eg, physicians in intensive care, emergency medicine, neurology, neurosurgery, pulmonology) who may also participate in the end-of-life care of potential donors in various clinical settings. It is hoped that this guidance will assist practitioners and their sponsoring organizations in preserving their duty of care, protecting the interests of dying patients, and fulfilling best practices for organ and tissue donation.

Serum Biomarkers Help Predict Attention Problems in Critically Ill Children With Traumatic Brain Injury

Objective: To evaluate the association between acute serum biomarkers, and the changes in attention at 1 year following traumatic brain injury. Design and Setting: A prospective observational and laboratory study conducted in PICUs at five Canadian children’s hospitals. Study Population and Measurements: Fifty-eight patients aged 5 to 17 years with traumatic brain injury were enrolled in the study. Nine brain-specific and inflammatory serum protein biomarkers were measured multiple times over the first week following injury. Attention was measured at “baseline” to represent pre-injury function and at 1 year following injury using the Conners Third Parent Rating Scale. Results: Compared with baseline, there were significantly more clinical symptoms of inattention at 1 year post injury. The Glasgow Coma Scale score, age at injury, baseline levels of inattention, and highest levels of serum biomarkers were used to estimate the probability of developing inattention. These independent variables were first evaluated individually followed by combinations of the best predictors using area under the receiver operating characteristic curve analyses. A combination of high baseline levels of inattention and high serum levels of the biomarker neuron-specific enolase was the best predictor for inattention. Glasgow Coma Scale and age at injury were not associated with inattention at 1 year post injury. Conclusions: Combining baseline assessment of attention with measurement of serum biomarkers shows promise as reliable, early predictors of long-term attention after childhood traumatic brain injury.