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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01173393
Registration number
NCT01173393
Ethics application status
Date submitted
26/07/2010
Date registered
2/08/2010
Date last updated
22/01/2015
Titles & IDs
Public title
Rapid Infusion of Cold Normal Saline During CPR for Patients With Out-of-hospital Cardiac Arrest
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Scientific title
The RINSE Trial: Rapid Infusion of Cold Saline During CPR for Patients With Cardiac Arrest
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Secondary ID [1]
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435/09 B
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Universal Trial Number (UTN)
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Trial acronym
RINSE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Out-of-hospital Cardiac Arrest
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - PARAMEDIC COOLING
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.
Treatment: Surgery: PARAMEDIC COOLING
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.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Survival at hospital discharge
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Assessment method [1]
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Timepoint [1]
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At hospital discharge or 28 days
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Secondary outcome [1]
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Quality of Life
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Assessment method [1]
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Timepoint [1]
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6 months
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Secondary outcome [2]
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Return of Spontaneous Circulation
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Assessment method [2]
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Timepoint [2]
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within 60 minutes of arrest
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2014
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Sample size
Target
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Accrual to date
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Final
1220
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Ambulance Victoria - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Ambulance Victoria
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Western Australian Ambulance Service
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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South Australian Ambulance Service
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT01173393
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Trial related presentations / publications
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. 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. 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. 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. 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.
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Public notes
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Contacts
Principal investigator
Name
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Stephen A Bernard, MD
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Address
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Ambulance Victoria
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01173393
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