Rapid Infusion of Cold Normal Saline During CPR for Patients With Out-of-hospital Cardiac Arrest

NCT01173393 | Completed Phase 3 DMC

• 1 other identifier: 435/09 B
• Study Type: interventional
• Target: 1,220
• Locations: 1 country
• Sites: 1

Brief Summary

That paramedic core cooling during CPR using a rapid infusion of ice-cold (4 degrees C) large-volume (30mL/kg) normal saline improves outcome at hospital discharge compared with standard care in patients with out-of-hospital cardiac arrest.

Conditions

Out-of-hospital Cardiac Arrest

Keywords

out of hospital cardiac arrest; OHCA; EMS; Emergency medical System; non-VF; non-ventricular fibrillation

Outcome Measures

Primary Outcomes (1)

• Survival at hospital discharge

  At hospital discharge or 28 days

Secondary Outcomes (2)

• Quality of Life

  6 months

• Return of Spontaneous Circulation

  within 60 minutes of arrest

Study Arms (1)

Standard Treatment

NO INTERVENTION

For patients randomised to hospital cooling: * LMA/ Intubation and ventilation with 100% oxygen * Measure temperature using tympanic probe and record * Insert IV line and administer drugs as per protocol * Fluid challenge with standard temperature saline only as per current guideline (suspected hypovolemia) * Post resuscitation: midazolam 1-5 mg only to maintain LMA/ intubation as needed. * Pancuronium 8 mg only if intubation unable to be maintained with midazolam. After arrival at the Emergency Department, all patients receive standard care.

Procedure: PARAMEDIC COOLING

Interventions

PARAMEDIC COOLING PROCEDURE

For patients randomised to paramedic cooling: * LMA/ Intubation and ventilation with 100% oxygen * Measure temperature using tympanic probe and record * Paramedic cooling using infusion of 20mL/kg cold fluid via IV during CPR * If temperature \>34.5ºC, infuse further 10mL/kg stat * After ROSC, infuse further (max 2 litres) ice-cold saline * If shivering occurs post resuscitation and intubated, administer midazolam 2-5mg IV and pancuronium 8 mg.

Also known as: Intervention arm

Standard Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are adults \> 18 years/ are in cardiac arrest (pulseless) on arrival of paramedics

You may not qualify if:

• In cardiac arrest following trauma or suspected intra-cranial bleeding/ obviously pregnant/ Dependant on others for activities of daily living (ie any assistance with activities of daily living, in supported care or nursing home residents) or have pre-existing significant neurological injury,Likely to be "Not for Resuscitation" and/or admission to the Intensive Care Unit because of terminal disease or advanced age, Patients who are hypothermic already and are confirmed to be on temperature measurement/ in-hospital cardiac arrest.

Sponsors & Collaborators

• Ambulance Victoria: lead
• Western Australian Ambulance Service: collaborator
• South Australian Ambulance Service: collaborator

Study Sites (1)

Ambulance Victoria

Melbourne, Australia

Location

Related Publications (5)

• Bernard SA, Rosalion A. Therapeutic hypothermia induced during cardiopulmonary resuscitation using large-volume, ice-cold intravenous fluid. Resuscitation. 2008 Feb;76(2):311-3. doi: 10.1016/j.resuscitation.2007.07.017. Epub 2007 Aug 31.

  PMID: 17765383 BACKGROUND

• Bernard SA, Smith K, Cameron P, Masci K, Taylor DM, Cooper DJ, Kelly AM, Silvester W; Rapid Infusion of Cold Hartmanns Investigators. Induction of prehospital therapeutic hypothermia after resuscitation from nonventricular fibrillation cardiac arrest*. Crit Care Med. 2012 Mar;40(3):747-53. doi: 10.1097/CCM.0b013e3182377038.

  PMID: 22020244 BACKGROUND

• Bernard SA, Smith K, Cameron P, Masci K, Taylor DM, Cooper DJ, Kelly AM, Silvester W; Rapid Infusion of Cold Hartmanns (RICH) Investigators. Induction of therapeutic hypothermia by paramedics after resuscitation from out-of-hospital ventricular fibrillation cardiac arrest: a randomized controlled trial. Circulation. 2010 Aug 17;122(7):737-42. doi: 10.1161/CIRCULATIONAHA.109.906859. Epub 2010 Aug 2.

  PMID: 20679551 BACKGROUND

• Bernard SA, Smith K, Finn J, Hein C, Grantham H, Bray JE, Deasy C, Stephenson M, Williams TA, Straney LD, Brink D, Larsen R, Cotton C, Cameron P. Induction of Therapeutic Hypothermia During Out-of-Hospital Cardiac Arrest Using a Rapid Infusion of Cold Saline: The RINSE Trial (Rapid Infusion of Cold Normal Saline). Circulation. 2016 Sep 13;134(11):797-805. doi: 10.1161/CIRCULATIONAHA.116.021989. Epub 2016 Aug 25.

  PMID: 27562972 DERIVED

• Deasy C, Bernard S, Cameron P, Jacobs I, Smith K, Hein C, Grantham H, Finn J; RINSE investigators. Design of the RINSE trial: the rapid infusion of cold normal saline by paramedics during CPR. BMC Emerg Med. 2011 Oct 13;11:17. doi: 10.1186/1471-227X-11-17.

  PMID: 21995804 DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Study Officials

• Stephen A Bernard, MD

  Ambulance Victoria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Advisor

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: August 2, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 22, 2015

Record last verified: 2015-01

Locations

AU (1)