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

This study is currently recruiting participants.
Verified December 2011 by Ambulance Victoria
Sponsor:
Collaborators:
Western Australian Ambulance Service
South Australian Ambulance Service
Information provided by (Responsible Party):
Stephen Bernard, Ambulance Victoria
ClinicalTrials.gov Identifier:
NCT01173393
First received: July 26, 2010
Last updated: December 22, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Out-of-hospital Cardiac Arrest
 Procedure: PARAMEDIC COOLING
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The RINSE Trial: Rapid Infusion of Cold Saline During CPR for Patients With Cardiac Arrest

Resource links provided by NLM:

MedlinePlus related topics: Cardiac Arrest
U.S. FDA Resources

Further study details as provided by Ambulance Victoria:

Primary Outcome Measures:
  • Survival at hospital discharge [ Time Frame: At hospital discharge or 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Return of Spontaneous Circulation [ Time Frame: within 60 minutes of arrest ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2512
Study Start Date: July 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard Treatment

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

For patients randomised to paramedic cooling:

  • LMA/ Intubation and ventilation with 100% oxygen
  • Measure temperature using tympanic probe and record
  • Infuse 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.
Other Name: Intervention arm

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Patients in cardiac arrest on arrival of paramedics and who:

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

Exclusion Criteria: Patients who are:

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173393

Contacts
Contact: Stephen Bernard, MD S.Bernard@alfred.org.au

Locations
Australia
Ambulance Victoria Recruiting
Melbourne, Australia
Contact: Stephen Bernard, MD         s.bernard@alfred.com.au    
Principal Investigator: Stephen Bernard, MD            
Sponsors and Collaborators
Ambulance Victoria
Western Australian Ambulance Service
South Australian Ambulance Service
Investigators
Principal Investigator: Stephen A Bernard, MD Ambulance Victoria
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Stephen Bernard, Medical Advisor, Ambulance Victoria
ClinicalTrials.gov Identifier: NCT01173393     History of Changes
Obsolete Identifiers: NCT01172678
Other Study ID Numbers: 435/09 B
Study First Received: July 26, 2010
Last Updated: December 22, 2011
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Ambulance Victoria:
out of hospital cardiac arrest
OHCA
EMS
 Emergency medical System
non-VF
non-ventricular fibrillation

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013