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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
Scientific title
The RINSE Trial: Rapid Infusion of Cold Saline During CPR for Patients With Cardiac Arrest
Secondary ID [1] 0 0
435/09 B
Universal Trial Number (UTN)
Trial acronym
RINSE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Out-of-hospital Cardiac Arrest 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survival at hospital discharge
Timepoint [1] 0 0
At hospital discharge or 28 days
Secondary outcome [1] 0 0
Quality of Life
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Return of Spontaneous Circulation
Timepoint [2] 0 0
within 60 minutes of arrest

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
Accrual to date
Final
1220
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Ambulance Victoria - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Ambulance Victoria
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Western Australian Ambulance Service
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
South Australian Ambulance Service
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01173393
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.
Public notes

Contacts
Principal investigator
Name 0 0
Stephen A Bernard, MD
Address 0 0
Ambulance Victoria
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01173393