Design of the RINSE Trial: The Rapid Infusion of cold Normal Saline by paramedics during CPR

This paper describes the methodology for a definitive multi-centre, randomised, controlled trial of paramedic cooling during CPR compared with standard treatment. Paramedic cooling during CPR will be achieved using a rapid infusion of large volume (20-40 mL/kg to a maximum of 2 litres) ice-cold (4°C) normal saline.The primary outcome measure is survival at hospital discharge. Secondary outcome measures are rates of return of spontaneous circulation, rate of survival to hospital admission, temperature on arrival at hospital, and 12 month quality of life of survivors.This trial will test the effect of the administration of ice cold saline during CPR on survival outcomes. If this simple treatment is found to improve outcomes, it will have generalisability to prehospital services globally.ClinicalTrials.gov: NCT01172678Cardiovascular disease is a leading cause of premature death in Australia [1]. More than half of these deaths (approximately 25,000 per year) occur prior to hospital arrival. Despite sophisticated emergency medical service responses to sudden cardiac arrest, less than half of sudden cardiac arrest patients are able to be resuscitated by paramedics [2]. For those who are initially resuscitated and transported to hospital, the prognosis is still poor, particularly in rural areas [3]. Much of the mortality and morbidity after hospital admission is due to the anoxic brain injury sustained during the cardiac arrest [4].One major recent advance in the treatment of severe anoxic brain injury following out-of-hospital cardiac arrest is therapeutic hypothermia (TH). When induced after resuscitation, this treatment was shown to improve neurological and overall outcomes in two randomized, controlled clinical trials [5,6]. The International Liaison Committee on Resuscitation (ILCOR) now recommends TH (33°C for 12-24 hours) as soon as possible for patients who remain comatose after resuscitation from out-of-hospital cardiac arrest for shockable rhythms and suggests th