[Randomized controlled clinical trials with barbiturate treatment after cardiac arrest in the United States. Ethical and medicolegal aspects (author's transl)].
Brain protection during ischemia by barbiturates has been clearly demonstrated in many different experiments. Only recently the therapeutic value of large doses of thiopental administered early after cerebral circulatory arrest has been demonstrated experimentally in monkey. Noncontrolled studies in humans also indicate beneficial effect, however the treatment is not without potential complication. Controlled randomized studies in humans are needed to document its beneficial effect. Such studies have several unique medico-legal and ethical implications since the treatment has to be started in an unconscious patient and as early as possible after a totally unexpected cardiac arrest. Informed consent, ethical and medicolegal consideration of randomized controlled clinical trials is discussed and a modified approach to clinical trials in humans is suggested. The modification would not alter the scientific value of the studies, but resolve the ethical and medico-legal problems.
D001463:Barbiturates / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004992:Ethics, Medical; D006323:Heart Arrest / Q000188:drug therapy*; D006801:Humans; D007258:Informed Consent; D007880:Legislation, Drug; D011897:Random Allocation; D013874:Thiopental / Q000627:therapeutic use; D014481:United States
D001463:Barbiturates; D013874:Thiopental
Essais aléatoires cliniques des barbituriques dans le traitement de l'arrêt cardiaque aux Etats-unis. Aspects moraux et légaux relatifs.