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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 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: January 8, 2014
Last verified: January 2014
  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:


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 2015
Estimated Primary Completion Date: July 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: January 8, 2014
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
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 30, 2014