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| Name | Class |
|---|---|
| University Hospital Hradec Kralove | OTHER |
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Type of study: Pilot prospective nonrandomized feasibility clinical study.
Aim of the study: To assess the feasibility of pre-hospital therapeutic mild hypothermia in patients successfully resuscitated from out-of-hospital cardiac arrest in the setting of prehospital and hospital care in Czech republic.
Evaluated hypothesis: Pre-hospital initiation of therapeutic mild hypothermia by rapid administration of intravenous bolus of cold crystalloids is simple, safe, effective and is a feasible procedure to significantly decrease body core temperature during patient's transport to the hospital in Czech republic.
The study is observational and does not evaluate any new drug, therapeutic procedure or diagnostic procedure. It is evaluating a known therapeutic procedure, therapeutic mild hypothermia, induced by known technique, cold crystalloid infusion, widely accepted in hospital-related postresuscitative care. However, even its prehospital usage has been published.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehospital hypothermia group | All patients included to the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Induction of therapeutic mild hypothermia | Procedure | Rapid administration of 4°C cold normal saline to the peripheral vein, dose 5 - 30 ml/kg, to decrease body core temperature below 34°C |
| Measure | Description | Time Frame |
|---|---|---|
| Effectivity measure - reached cooling rate calculated in °C/30 min | Assessed during prehospital phase |
| Measure | Description | Time Frame |
|---|---|---|
| Appearance of adverse events and complications during prehospital induction of therapeutic mild hypothermia | Assessed during prehospital phase | |
| Achievement of favourable neurological outcome at the hospital discharge | Assessed during prehospital and in-hospital phase |
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Inclusion Criteria:
Exclusion Criteria:
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Out-of-hospital cardiac arrest patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roman Skulec, MD | Contact | 00420 777577497 | skulec@email.cz | |
| Anatolij Truhlar, MD | Contact | 00420 495 833 497 | atruhlar@seznam.cz |
| Name | Affiliation | Role |
|---|---|---|
| Roman Skulec, MD | Emergency Medical Service of the Central Bohemian Region, Czech Republic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Medical Service of the Central Bohemian Region | Recruiting | Beroun | Central Bohemia | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21176218 | Derived | Skulec R, Truhlar A, Seblova J, Dostal P, Cerny V. Pre-hospital cooling of patients following cardiac arrest is effective using even low volumes of cold saline. Crit Care. 2010;14(6):R231. doi: 10.1186/cc9386. Epub 2010 Dec 22. |
| Label | URL |
|---|---|
| Web pages of Emergency Medical Service of the Central Bohemian Region, Czech republic | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 18, 2010 | |
| Reset | Jul 16, 2010 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 18, 2010 | Jul 16, 2010 |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Overall prehospital and in-hospital mortality | Assessed during prehospital and in-hospital phase |
| The best neurological outcome achieved anytime during hospital stay | Assessed during in-hospital phase |
| Hradec Kralove Region Emergency Medical Services, Czech republic | Recruiting | Hradec Králové | Region of Hradec Kralove | Czechia |
|
| Web pages of Hradec Kralove Region Emergency Medical Services, Czech republic | View source |