Non-environmental HypothermiaPhase 4NCT01155622
Trial of Different Hypothermia Temperatures in Patients Recovered From Out-of-hospital Cardiac Arrest
A Phase 4 study testing Endovascular Cooling in people with Non-environmental Hypothermia and Cardiac Arrest, run by Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Mild therapeutic hypothermia in the temperature range of 32º - 34ºC. improves survival in patients recovered from a ventricular fibrillation cardiac arrest. The same therapy is suggested with less evidence for asystole as first rhythm after cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-environmental Hypothermia, Cardiac Arrest
- What is being tested?
- Endovascular Cooling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2008to May 2012
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Resuscitated patients from a cardiac arrest with first rhythm of ventricular fibrillation or asystole
- Witnessed cardiac arrest
- Estimated delay between cardiac arrest and advanced resuscitation < 20 min.
- Resuscitation time from first contact to recovery of spontaneous circulation < 60 min.
- Hemodynamic stability (Mean blood pressure [BP] >60 mmHg), with or without inotropic drugs, before randomization
- Glasgow coma score <9 without sedation before randomization
Who cannot join
- Pregnant women or suspected pregnancy or fertile women without a negative pregnancy test
- Suspected non-cardiac arrest caused coma
- Electrical instability (uncontrollable life-threatening arrhythmias)
- Hemodynamic instability (Mean BP ≤60 mmHg), refractory to volume infusion or inotropic drugs
- Refractory hypoxemia (saturation <85% with FiO2=100%)
- Previous known terminal illness
- Active bleeding or known coagulopathy
- Opposition from patient's family to enter the study
Trial locations and contacts
1 site in 1 country.
Spain1 site
Intensive Cardiac Care Unit. Hospital Universitario la Paz
Madrid, Madrid, 28046
About this study
Official title: Pilot Randomized Clinical Trial Comparing the Efficacy of Two Different Hypothermia Temperatures for Treatment of Comatose Patients Recovered From an Out-of-hospital Cardiac Arrest
Mild therapeutic hypothermia in the temperature range of 32º - 34ºC. improves survival in patients recovered from a ventricular fibrillation cardiac arrest. The same therapy is suggested with less evidence for asystole as first rhythm after cardiac arrest. The purpose of this study is to determine whether different temperature targets (32º vs 34º) may have different efficacy in the treatment of post-cardiac arrest patients. If successful, this pilot study will eventually form the basis for a larger, multicentric randomized clinical trial.
Read the detailed description
Patients admitted consecutively were potentially eligible for the study if they had a witnessed out-off hospital cardiac arrest (OHCA) apparently related to heart disease and an interval of <60 minutes from collapse to return of spontaneous circulation (ROSC). Additional inclusion criteria were:
- Age >18 years.
- Initial registered rhythm of a shockable rhythm (ventricular fibrillation or pulseless ventricular tachycardia) or asystole.
Exclusion criteria were:
- Known pregnancy
- Glasgow Coma Scale score after ROSC >8.
- Cardiogenic shock (a systolic blood pressure of <80 mm Hg despite inotrope infusion >30 minutes).
- Other nonshockable rhythms (pulseless electric activity).
- Terminal illness present before the OHCA.
- Possible causes of coma other than cardiac arrest (drug overdose, head trauma, or cerebrovascular accident).
- Conditions
- Non-environmental Hypothermia, Cardiac Arrest
- Being tested
- Endovascular Cooling
- Keywords
- Hypothermia, induced, Cardiac arrest, Disability evaluation, Cardiac arrhythmia, Ventricular function, Internal cooling, Out-of-hospital cardiac arrest, Post-cardiac arrest syndrome
- Medical subject headings
- Heart Arrest, Hypothermia, Arrhythmias, Cardiac, Out-of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular CoolingProcedure or surgery
Infusion of <8°C cold saline followed by the implantation of the Icy 9.3F 38-cm catheter (ZOLL Medical Corporation, Chelmsford, MA) placed in the inferior vena cava through a femoral vein connected to the Thermogard XP Temperature Management System (ZOLL Medical Corporation). Cooling was set at a maximum rate with a target temperature of 32°C or 34°C according to randomization.
| Study group | Role | What they receive |
|---|---|---|
| 32º Celsius | Active comparator | Endovascular Cooling was set at a target temperature of 32°C Receives: Procedure: Endovascular Cooling |
| 34º Celsius | Active comparator | Endovascular Cooling was set at a target temperature of 32°C Receives: Procedure: Endovascular Cooling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival free from severe dependence (Barthel index <60)
Measured: 6 months
Secondary outcomes (4)
Survival at 6 months
Measured: 6 months
Barthel Index at 6 months
Measured: 6 months
Life threatening arrhythmias in different hypothermia temperatures
New life-threatening arrhythmias during hypothermia: ventricular fibrillation, sustained (>30 sec.) monomorphic or polymorphic ventricular tachycardia, extreme bradycardia (heart rate <35 bpm. and/or pauses >3 sec.)
Measured: 48 hours (during hypothermia)
Impact on ventricular function of different hypothermia temperatures
Echocardiographic evaluation of possible impact of different hypothermia temperatures on ventricular diastolic and systolic function
Measured: 48 hours During hypothermia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startMar 2008
- Primary completionApr 2012
- Study completionMay 2012
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 Non-environmental HypothermiaStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esteban Lopez de Sa Areses, Hospital Universitario La Paz
- Investigators
- Esteban Lopez-de-Sa, MD, FESC, Principal investigator, Intensive Cardiac Care Unit. Department of Cardiology. Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155622
- Sponsor's protocol ID
- Hypothermia_32vs34
- Status last verified
- Dec 2012
- First submitted
- 1 Jul 2010
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lopez-de-Sa E, Rey JR, Armada E, Salinas P, Viana-Tejedor A, Espinosa-Garcia S, Martinez-Moreno M, Corral E, Lopez-Sendon J. Hypothermia in comatose survivors from out-of-hospital cardiac arrest: pilot trial comparing 2 levels of target temperature. Circulation. 2012 Dec 11;126(24):2826-33. doi: 10.1161/CIRCULATIONAHA.112.136408. Epub 2012 Nov 6.
PubMed 23136160
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Clinical Trial Comparing the Efficacy of Two Different Hypothermia Temperatures for Treatment of Comatose Patients Recovered From an Out-of-hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT01155622
- Acronym / sponsor ID
- Hypothermia_32vs34
- Conditions
- Non-environmental Hypothermia, Cardiac Arrest
- Keywords
- Hypothermia, induced, Cardiac arrest, Disability evaluation, Cardiac arrhythmia, Ventricular function, Internal cooling, Out-of-hospital cardiac arrest, Post-cardiac arrest syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 2 Jul 2010 (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.
Mild therapeutic hypothermia in the temperature range of 32º - 34ºC. improves survival in patients recovered from a ventricular fibrillation cardiac arrest. The same therapy is suggested with less evidence for asystole as first rhythm after cardiac arrest. The purpose of this study is to determine whether different temperature targets (32º vs 34º) may have different efficacy in the treatment of post-cardiac arrest patients. If successful, this pilot study will eventually form the basis for a larger, multicentric randomized clinical trial.
Detailed description
Patients admitted consecutively were potentially eligible for the study if they had a witnessed out-off hospital cardiac arrest (OHCA) apparently related to heart disease and an interval of <60 minutes from collapse to return of spontaneous circulation (ROSC). Additional inclusion criteria were:
- Age >18 years.
- Initial registered rhythm of a shockable rhythm (ventricular fibrillation or pulseless ventricular tachycardia) or asystole.
Exclusion criteria were:
- Known pregnancy
- Glasgow Coma Scale score after ROSC >8.
- Cardiogenic shock (a systolic blood pressure of <80 mm Hg despite inotrope infusion >30 minutes).
- Other nonshockable rhythms (pulseless electric activity).
- Terminal illness present before the OHCA.
- Possible causes of coma other than cardiac arrest (drug overdose, head trauma, or cerebrovascular accident).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 32º Celsius | Active comparator | Procedure: Endovascular CoolingEndovascular Cooling was set at a target temperature of 32°C |
| 34º Celsius | Active comparator | Procedure: Endovascular CoolingEndovascular Cooling was set at a target temperature of 32°C |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18
- Resuscitated patients from a cardiac arrest with first rhythm of ventricular fibrillation or asystole
- Witnessed cardiac arrest
- Estimated delay between cardiac arrest and advanced resuscitation < 20 min.
- Resuscitation time from first contact to recovery of spontaneous circulation < 60 min.
Key exclusion criteria (8 listed)
- Pregnant women or suspected pregnancy or fertile women without a negative pregnancy test
- Suspected non-cardiac arrest caused coma
- Electrical instability (uncontrollable life-threatening arrhythmias)
- Hemodynamic instability (Mean BP ≤60 mmHg), refractory to volume infusion or inotropic drugs
- Refractory hypoxemia (saturation <85% with FiO2=100%)
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 |
|---|---|---|
| Endovascular CoolingInfusion of <8°C cold saline followed by the implantation of the Icy 9.3F 38-cm catheter (ZOLL Medical Corporation, Chelmsford, MA) placed in the inferior vena cava through a femoral vein connected to the Thermogard XP Temperature Management System (ZOLL Medical Corporation). Cooling was set at a maximum rate with a target temperature of 32°C or 34°C according to randomization. | Procedure or surgery | 32º Celsius, 34º Celsius |
Primary outcome
Survival free from severe dependence (Barthel index <60)
Time frame: 6 months
4 secondary outcomes
Survival at 6 months
Time frame: 6 months
Barthel Index at 6 months
Time frame: 6 months
Life threatening arrhythmias in different hypothermia temperatures
Time frame: 48 hours (during hypothermia)
Impact on ventricular function of different hypothermia temperatures
Time frame: 48 hours During hypothermia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2012.
- Results publication: PubMed 23136160Lopez-de-Sa E, Rey JR, Armada E, Salinas P, Viana-Tejedor A, Espinosa-Garcia S, Martinez-Moreno M, Corral E, Lopez-Sendon J. Hypothermia in comatose survivors from out-of-hospital cardiac arrest: pilot trial comparing 2 levels of target temperature. Circulation. 2012 Dec 11;126(24):2826-33. doi: 10.1161/CIRCULATIONAHA.112.136408. Epub 2012 Nov 6.
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.
Esteban Lopez-de-Sa, MD, FESC principal investigator
Intensive Cardiac Care Unit. Department of Cardiology. Hospital Universitario La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Endovascular Cooling in people with Non-environmental Hypothermia and Cardiac Arrest, run by Hospital Universitario La Paz at 1 site in Spain.
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 5 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival free from severe dependence (Barthel index <60) (time frame: 6 months). 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 NCT01155622, 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 5 Dec 2012.