Search

Despite its use since the 1960s, the safety or effectiveness of adrenaline as a treatment for cardiac arrest has never been comprehensively evaluated in a clinical trial. Although most studies have found that adrenaline increases the chance of return of spontaneous circulation for short periods, many studies found harmful effects on the brain and raise concern that adrenaline may reduce overall survival and/or good neurological outcome. The PARAMEDIC-2 trial seeks to determine if adrenaline is safe and effective in out-of-hospital cardiac arrest.This is a pragmatic, individually randomised, double blind, controlled trial with a parallel economic evaluation. Participants will be eligible if they are in cardiac arrest in the out-of-hospital environment and advanced life support is initiated. Exclusions are cardiac arrest as a result of anaphylaxis or life threatening asthma, and patient known or appearing to be under 16 or pregnant.8000 participants treated by 5 UK ambulance services will be randomised between December 2014 and August 2017 to adrenaline (intervention) or placebo (control) through opening pre-randomised drug packs. Clinical outcomes are survival to 30 days (primary outcome), hospital discharge, 3, 6 and 12 months, health related quality of life, and neurological and cognitive outcomes (secondary outcomes).Trial registration (ISRCTN73485024).

s / Resuscitation 96S (2015) 43–157 119 makes it difficult to obtain informed consent (IC) for clinical studies/trials. Some countries have codified the conditions inwhich the necessity of trial consent is waived in emergency research. Inmany countries, however, IC requirement remains a formidable barrier to conducting such studies. It is important to examine which conditions are effective and advisable in promoting clinical studies/trials in this field. Methods: From the WHO ICTRP (International Clinical Trials Registry Platform) database, trial information, registered in the between 2005 and 2014, was extracted and aggregated for several European countries, the United States and Japan. Overall numbers of registered trials, and those in emergency situations (entries which have “emergency” in title, condition or intervention) were counted. They were tabulated by the study design and countries. Results: Overall, 79,998 clinical trials were registered during the study period. Among this, the number of global clinical trials was 9296(11.6%). The total number of randomised controlled trial (RCT)was 30,717 (38%). Thenumbers of trialswithRCTdesignwere 12,022 (15%) in Europe, 10502 (13%) in the U.S., and 13,317 (17%) in Japan. Among all of clinical trials, 286 (0.36%) were the number of emergency clinical trials; 68 (24%) in Europe, 91 (32%) in the U.S., and 24 (8%) in Japan. The proportions of emergency trials with RCT among all RCT clinical trials in each country were 0.32% in Europe, 0.53% in the U.S., and 0.05% in Japan. Conclusion: There are not many clinical trials conducted in emergency situations. The case is more remarkable with RCTs. This might reflect the difficulty in implementing research due to the conditions and considerations specific to this field. However, the number of RCTwas relatively larger in the U.S., where the guidance on exception from informed consent requirements for emergency research was issued by its regulatory authority. More international exchange of information and discussion is advisable.1,2