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

Conor Deasy,Cindy Hein,Karen Smith,Peter Cameron,Ian Jacobs,Stephen Bernard,Hugh Grantham,Judith Finn

doi:10.1186/1471-227x-11-17

Abstract

BackgroundThe International Liaison Committee on Resuscitation (ILCOR) now recommends therapeutic hypothermia (TH) (33°C for 12-24 hours) as soon as possible for patients who remain comatose after resuscitation from shockable rhythm in out-of-hospital cardiac arrest and that it be considered for non shockable rhythms. The optimal timing of TH is still uncertain. Laboratory data have suggested that there is significantly decreased neurological injury if cooling is initiated during CPR. In addition, peri-arrest cooling may increase the rate of successful defibrillation. This study aims to determine whether paramedic cooling during CPR improves outcome compared standard treatment in patients who are being resuscitated from out-of-hospital cardiac arrest.Methods/DesignThis 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.DiscussionThis 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.Trial RegistrationClinicalTrials.gov: NCT01172678

Highlights

The International Liaison Committee on Resuscitation (ILCOR) recommends therapeutic hypothermia (TH) (33°C for 12-24 hours) as soon as possible for patients who remain comatose after resuscitation from shockable rhythm in out-of-hospital cardiac arrest and that it be considered for non shockable rhythms
This trial will test the effect of the administration of ice cold saline during CPR on survival outcomes
We aim to determine whether paramedic cooling during CPR using a rapid infusion of large volume (20-40 mL/kg) ice-cold (4°C) normal saline improves outcome compared with standard treatment in patients who are being resuscitated from out-of-hospital cardiac arrest

Summary

Introduction

The International Liaison Committee on Resuscitation (ILCOR) recommends therapeutic hypothermia (TH) (33°C for 12-24 hours) as soon as possible for patients who remain comatose after resuscitation from shockable rhythm in out-of-hospital cardiac arrest and that it be considered for non shockable rhythms. This study aims to determine whether paramedic cooling during CPR improves outcome compared standard treatment in patients who are being resuscitated from out-of-hospital cardiac arrest. 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, 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].

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