Cardiac ArrestPRE-COOLNCT00915421
Pre-Hospital Cooling in Cardiac Arrest Patients
An observational study of Cardiac Arrest, run by Emergency Medical Service of the Central Bohemian Region, Czech Republic at 2 sites in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Induction of therapeutic mild hypothermia
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 2 sitesCzechia
- Study dates
- Jul 2007to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Out-of-hospital cardiac arrest patients
Who may be able to join
- patients resuscitated from out-of-hospital cardiac arrest
- remaining comatose and requiring mechanical ventilation
Who cannot join
- cardiac arrest of traumatic etiology
- patient conscious after short cardiopulmonary resuscitation
- coma of other origin than cardiac arrest (e.g., epileptic paroxysm, intoxication etc.)
- severe acute heart failure
- accidental hypothermia below 30°C
- bradycardia requiring transcutaneous cardiac pacing
Show all 12Show fewer
- status Do Not Resuscitate or Do Not Intubate
- severe circulatory shock
- severe life threatening cardiac arrhythmias
- severe and life threatening bleeding
- severe sepsis
- any common opinion of intervening team of unfitness of induction of therapeutic mild hypothermia
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites, 2 recruiting
- Recruiting
Emergency Medical Service of the Central Bohemian Region
Beroun, Central Bohemia
Roman Skulec, MD, 00420 777 577 497, skulec@email.cz
Anatolij Truhlar, MD, 00420 495 833 497, atruhlar@seznam.cz
- Recruiting
Hradec Kralove Region Emergency Medical Services, Czech republic
Hradec Králové, Region of Hradec Kralove
Anatolij Truhlar, MD, 00420 495 833 497, atruhlar@seznam.cz
Roman Skulec, MD, 00420 777 577 497, skulec@email.cz
About this study
Official title: Pre-Hospital Cooling in Cardiac Arrest Patients - Feasibility Pilot Study
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.
Read more
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.
- Conditions
- Cardiac Arrest
- Being tested
- Induction of therapeutic mild hypothermia
- Keywords
- cardiac arrest, therapeutic hypothermia, Postresuscitative disease
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction of therapeutic mild hypothermiaProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Prehospital hypothermia group | All patients included to the study Receives: Procedure: Induction of therapeutic mild hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectivity measure - reached cooling rate calculated in °C/30 min
Measured: Assessed during prehospital phase
Secondary outcomes (4)
Appearance of adverse events and complications during prehospital induction of therapeutic mild hypothermia
Measured: Assessed during prehospital phase
Achievement of favourable neurological outcome at the hospital discharge
Measured: Assessed during prehospital and in-hospital phase
Overall prehospital and in-hospital mortality
Measured: Assessed during prehospital and in-hospital phase
The best neurological outcome achieved anytime during hospital stay
Measured: Assessed during in-hospital phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startJul 2007
- Primary completionJul 2009 (estimated)
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emergency Medical Service of the Central Bohemian Region, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Hradec Kralove
- Investigators
- Roman Skulec, MD, Principal investigator, Emergency Medical Service of the Central Bohemian Region, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915421
- Sponsor's protocol ID
- SCK-KVK-001
- Acronym
- PRE-COOL
- Status last verified
- Jun 2009
- First submitted
- 5 Jun 2009
- Last updated
- 8 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21176218
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Hospital Cooling in Cardiac Arrest Patients - Feasibility Pilot Study
- ClinicalTrials.gov ID
- NCT00915421
- Acronym / sponsor ID
- PRE-COOL / SCK-KVK-001
- Conditions
- Cardiac Arrest
- Keywords
- cardiac arrest, therapeutic hypothermia, Postresuscitative disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Emergency Medical Service of the Central Bohemian Region, Czech RepublicUniversity, hospital or other
- Collaborators
- University Hospital Hradec Kralove
- Study start
- Jul 2007
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 8 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prehospital hypothermia group | – | Procedure: Induction of therapeutic mild hypothermiaAll patients included to the study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Out-of-hospital cardiac arrest patients
Key inclusion criteria (2 listed)
- patients resuscitated from out-of-hospital cardiac arrest
- remaining comatose and requiring mechanical ventilation
Key exclusion criteria (12 listed)
- cardiac arrest of traumatic etiology
- patient conscious after short cardiopulmonary resuscitation
- coma of other origin than cardiac arrest (e.g., epileptic paroxysm, intoxication etc.)
- severe acute heart failure
- accidental hypothermia below 30°C
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Induction of therapeutic mild hypothermiaRapid administration of 4°C cold normal saline to the peripheral vein, dose 5 - 30 ml/kg, to decrease body core temperature below 34°C | Procedure or surgery | Prehospital hypothermia group |
Primary outcome
Effectivity measure - reached cooling rate calculated in °C/30 min
Time frame: Assessed during prehospital phase
4 secondary outcomes
Appearance of adverse events and complications during prehospital induction of therapeutic mild hypothermia
Time frame: Assessed during prehospital phase
Achievement of favourable neurological outcome at the hospital discharge
Time frame: Assessed during prehospital and in-hospital phase
Overall prehospital and in-hospital mortality
Time frame: Assessed during prehospital and in-hospital phase
The best neurological outcome achieved anytime during hospital stay
Time frame: Assessed during in-hospital phase
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2009.
- Derived from this study: PubMed 21176218Skulec 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.
- Web pages of Emergency Medical Service of the Central Bohemian Region, Czech republicLink provided by the sponsor.
- Web pages of Hradec Kralove Region Emergency Medical Services, Czech republicLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Skulec, MD principal investigator
Emergency Medical Service of the Central Bohemian Region, Czech Republic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by Emergency Medical Service of the Central Bohemian Region, Czech Republic at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roman Skulec, MD (00420 777577497, skulec@email.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectivity measure - reached cooling rate calculated in °C/30 min (time frame: Assessed during prehospital phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00915421, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2009.