Ethical and Legal Perspectives on the Treatment of Hypoxic Ischemic Encephalopathy in the Newborn.

Hypoxic ischemic encephalopathy (HIE) in neonates can cause severe, life-long functional impairments or death. Treatment of these neonates can involve ethically challenging questions about if, when, and how it may be appropriate to limit life-sustaining medical therapy. Further, parents whose infants suffer severe neurologic damage may seek recourse in the form of a medical malpractice lawsuit. This study uses several hypothetical cases to highlight important ethical and legal considerations in the care of infants with HIE.

Hipotermia inducida posparada cardiorrespiratoria / Induced hypothermia aftere cardiac arrest

Introducción. La muerte súbita cardiaca en el adulto es uno de los retos de la medicina cardiovascular. La parada cardiorrespiratoria (PCR) frecuentemente asocia daños neurológicos derivados de la hipoxia cerebral, y desencadena una serie de alteraciones celulo-tisulares que conducen a la lesión cerebral. La hipotermia terapéutica disminuye las demandas de oxígeno y actúa como protector. Objetivos. Describir la casuística de la hipotermia inducida (HI) pos PCR del Hospital Universitari de Bellvitge (HUB) desde 2009 hasta 2012. Elaborar una hoja de seguimiento del proceso de la hipotermia inducida. Reflejar la experiencia profesional de la HI pos PCR a través del seguimiento de un caso. Metodología. Estudio descriptivo retrospectivo de 54 casos, 45 hombres y 9 mujeres, con una edad media de 57 años (intervalo de 15 a 80) sometidos a HI pos PCR del HUB. Análisis de variables sociodemográficas, variables específicas y descripción de los criterios de inclusión de la HI. Diseño de registro de enfermería para plasmar los cuidados estandarizados que llevar a cabo durante el proceso de la HI y prueba piloto. Seguimiento de un paciente de 60 años que sufre PCR y a quien se somete a HI. Resultados. Principal causa de PCR: síndrome coronario agudo (SCA) (63 %). Ritmo inicial más representativo, taquicardia ventricular sin pulso/fibrilación ventricular (TVSP/FV) (68.5 %). Se objetiva mayor supervivencia en pacientes cuyas maniobras de RCP son inferiores a 30 minutos. La temperatura objetivo de los pacientes ha sido de 33 ºC durante 24 horas, a excepción de 5 casos, que se detuvieron por inestabilidad hemodinámica. Al alta hospitalaria 54 % son éxitus, 4 % presenta encefalopatía severa, 11 % encefalopatía leve y 31 % sin secuelas neurológicas. Se comprueba la aplicabilidad del registro de enfermería creado para el proceso de la HI, que permitió una visión global y rápida del procedimiento. Se describe la situación clínica del caso al ingreso, durante la HI, a las 48 horas, al alta de la Unidad Coronaria (UCC) y al alta hospitalaria. Discusión. Los datos recogidos en el centro de 2009 a 2012 de los pacientes con PCR candidatos a HI presentaron una favorable recuperación neurológica de los pacientes supervivientes. Asimismo, tienen mejor pronóstico los pacientes con PCR no prolongado, lo que coincide con estudios anteriores. Conclusiones. La HI es una terapia viable en el caso de pacientes que han sufrido PCR. Es importante realizar una valoración específica de cada uno de estos pacientes para posteriormente poder realizar la evaluación de los mismos (AU)

Introduction. Sudden cardiac death in adults remains a challenge in cardiovascular medicine. Cardiac arrest often drives neurological damage resulting from cerebral hypoxia, causing a series of cellulose tissue alterations that lead to brain injury. Therapeutic hypothermia decreases oxygen demand acting as protection to the brain. Objectives. To describe the casuistry of hypothermia after retourn of spontaneous circulation (ROSC) at Bellvitge University Hospital (BUH) from 2009 to 2012. Develop a tracking sheet of the induced hypothermia process. Reflect professional experience of induced hypothermia after cardiac arrest through a case. Methodology. Retrospective descriptive study of the 54 cases, 45 men and 9 women, aged between ages 57 (15 to 80) years old treated with hypothermia after ROSC at BUH. Analysis of soiodemographic variables, specific variables and description of the inclusion criteria for hypothermia. Design of nursing record to express standardized care to undertake during the HI and its pilot trial. Monitoring a 60 years old patient who suffers cardiopulmonary arrest and is subjected to hypothermia. Results. Leading cause of cardiopulmonary arrest is acute coronary syndrome (ACS) (63%). Most representative initial rhythm is pulseless ventricular tachycardia / ventricular fibrillation (PVT / VF) (68.5%). There is longer survival in patients whose CPR is less than 30 minutes. The target temperature of the patients was 33 °C for 24 hours, except for 5 patients who were stopped because of hemodynamic instability. At discharge, 54 % were exitus, 4 % had severe encephalopathy, 11 % mild encephalopathy and 31 % without neurological sequel. The applicability of the nursing record that was created for the HI process was checked, which allowed a fast overview of the procedure. It describes the clinical status of the case on admission, during the HI, at 48 hours, at discharge from the coronary care unit (CCU) and at discharge. Discussion. The data collected between 2009 and 2012 of patients with cardiopulmonary arrest candidates to hypothermia showed a favorable neurological recovery within the surviving patients. Additionally, patients with cardiopulmonary arrest not prolonged have a better prognosis agreeing with ROSC previous studies. Conclusions. Hypothermia is a viable therapy for patients who have undergone cardiopulmonary arrest. It is important to make a specific assessment of each case as well as agree the track record of care applied to these patients to subsequently allow their assessment (AU)

Ethical and practical issues relating to the global use of therapeutic hypothermia for perinatal asphyxial encephalopathy.

In intensive care settings in the developed world, therapeutic hypothermia is established as a therapy for term infants with moderate to severe neonatal encephalopathy due to perinatal asphyxia. Several preclinical, pilot and clinical trials conducted in such settings over the last decade have demonstrated that this therapy is safe and effective. The greatest burden of birth asphyxia falls, however, in low- and middle-income countries; it is still unclear whether therapeutic hypothermia is safe and effective in this context. In this paper, the issues around treatments that may be proven safe and effective in the developed world and the caution needed in translating these into different settings and populations are explored. It is argued that there are strong scientific and ethical reasons supporting the conduct of rigorous, randomised controlled trials of therapeutic hypothermia in middle-income settings. There also needs to be substantial and sustainable improvements in all facets of antenatal care and in the basic level of newborn resuscitation in low income countries. This will reduce the burden of disease and allow health workers to determine rapidly which infants are most eligible for potential neuroprotection.

Ethical challenges in the use of therapeutic hypothermia in Indian neonatal units.

Trials in developed countries have shown that therapeutic hypothermia reduces the risk of death or severe disability in infants with neonatal encephalopathy. Cooling has been adopted as a standard of care in some parts of the world. Some Indian neonatal units have considered or even embarked upon cooling encephalopathic term newborn infants. In this article we discuss some of the potential ethical questions that should be considered before introducing therapeutic hypothermia in an Indian setting. Evidence from previous trials may not be relevant given significant differences in the epidemiology of neonatal encephalopathy in countries like India. There is a possibility that hypothermia would be ineffective or harmful. The most appropriate way to answer these concerns would be to perform a large randomized controlled trial of cooling in India. However, such trials will also raise potential ethical challenges. Cooling may also affect decisions about treatment withdrawal, and may create uncertainty about prognosis. It may exacerbate ethical problems relating to lack of neonatal intensive care bed space.

Ethics and hypothermia treatment.

Hypothermia is the first effective neuroprotective intervention for newborns who are critically ill following a life-threatening asphyxial insult. It is not surprising that it has raised complex and controversial ethical dilemmas for investigators and clinicians. Given the history of iatrogenic disasters in neonatology, there has been an understandable reluctance to incorporate hypothermia into routine clinical practice until there is persuasive evidence from high quality randomised trials. This article reviews ethical issues that arose during the design of the original clinical trials, the implications of accumulating evidence of safety and efficacy, and the problems of ensuring informed parental participation in treatment decisions.

Cool heads: ethical issues associated with therapeutic hypothermia for newborns.

UNLABELLED: Hypothermia is the first treatment for newborns with hypoxic-ischaemic encephalopathy (HIE) with consistent evidence of a reduction in the risk of death or severe disability. This paper addresses a number of ethical and practical issues faced by clinicians as cooling moves from an experimental treatment into practice. These issues are not unique to therapeutic hypothermia. They include the extrapolation of evidence from trials to clinical care, as well as the impact of hypothermia on prognosis and withdrawal of life-sustaining treatment. CONCLUSION: Hypothermia is a promising new therapy, but further research will be necessary to help resolve some of the ethical concerns associated with its use in newborns with HIE .