Cardiac ArrestNCT02066753
The Cardiac Effects of Prolonged Hypothermia After Cardiac Arrest
A study testing Mild therapeutic hypothermia in people with Cardiac Arrest and Hypothermia, run by University of Aarhus at 2 sites in 2 countries.
Trial summary
This PhD study is a sub study in a randomized clinical controlled multicenter trial named "TTH48" (ClinicalTrials.gov Identifier: NCT01689077). The TTH48 trial examines prolonged mild therapeutic hypothermia ("MTH") at 32-34°C in 24 versus 48 hours with the primary outcome Cerebral Performance Category after 6 month… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Arrest, Hypothermia
- What is being tested?
- Mild therapeutic hypothermia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2013to Nov 2015
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resuscitated after cardiac arrest outside hospital with suspected cardiac triggering cause (and stabile circulation for at least 20 minutes after return of spontaneous circulation,
- Glasgow coma score < 8 and
- Age ≥ 18 years and < 80 years.
Who cannot join
- Cardiac arrest of suspected non-cardiac triggering cause (e.g. trauma, aortic dissection, massive bleeding, hypoxia or accidental hypothermia),
- >60 minutes from cardiac arrest to ROSC,
- Time from cardiac arrest until start of cooling >4 hours,
- Terminal illness,
- Coagulopathy (medical anticoagulation treatment including thrombolysis is not a contraindication),
- Unwitnessed arrests with asystolia as presenting rhythm,
Show all 15Show fewer
- Pregnancy,
- Persistent cardiogenic shock,
- Systolic blood pressure <80 mmHg despite vasoactive treatment and intra-aortic balloon pump
- CPC 3-4 before the cardiac arrest,
- Suspected/confirmed acute intra cerebral hemorrhage or stroke,
- Acute CABG or other operation in connection with performing CPR,
- Lack of consent from the relatives,
- Lack of consent from the GP and
- Lack of consent from the patient if he/she wakes up and is relevant.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Denmark1 site
Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Skejby
Aarhus N, Central Jutland, 8200
Norway1 site
Research Center of Emergency Medicine and Department of Anesthesiology and Intensive Care Medicine, Stavanger University Hospital
Stavanger, 4068
About this study
This PhD study is a sub study in a randomized clinical controlled multicenter trial named "TTH48" (ClinicalTrials.gov Identifier: NCT01689077).
The TTH48 trial examines prolonged mild therapeutic hypothermia ("MTH") at 32-34°C in 24 versus 48 hours with the primary outcome Cerebral Performance Category after 6 month in comatose out-of-hospital cardiac arrest patients.
THE OVERALL AIM OF THIS PhD STUDY IS TO INVESTIGATE THE CARDIAC FUNCTION AND THE HEMODYNAMICS BY BIOCHEMICAL CARDIAC MARKERS, ECHOCARDIOGRAPHY, BY ANALYZING THE USAGE OF INOTROPES/VASOPRESSORS AND BY ANALYZING ECG DATA FOR ARRHYTHMIAS IN THE 24 VERSUS 48 HOURS MTH GROUPS.
Read the detailed description
The PhD-study contains 3 sub studies:
- Study 1 estimates the extend of myocardial damage resulting from the primary arrest and from the reperfusion injuries: Area under the curve of cTnT and CK-MB as 12 repeated measurements and NT-proBNP as 4 measurements post arrest -Hypothesis: There is a statistically significantly greater release of the cardiac biomarkers cTnT and NT-proBNP quantified by the area under the curve in the 24 versus the 48 hours group in the intervention period from 24 to 72 hours.
- Study 2 investigates MTH´s influence on systolic and diastolic function by standard and Tissue Doppler (TDI) echocardiography after 24, 48 and 72 hours. The primary endpoint is mitral annular systolic velocity ("S´ max") -Primary hypothesis: There is statistically significant improvement in S' max from the time T24 to T72 in the 48 versus the 24 hours group. -Secondary hypothesis: There is statistically significantly better systolic function at T48 measured in terms of individual S' max-change in the 48 hours group (still hypothermic) versus the 24 hours group (reached normothermia).
- Study 3 investigates MTH´s influence on the need for vasopressor or inotrope and the duration of arrhythmias during the first 72 hours post arrest.
- Primary hypothesis: There is a statistically significantly increased tendency of arrhythmias in the 48 versus the 24 hours group measured in the period from T0 to T72.
- Secondary hypothesis: There is a statistically significantly reduced need for inotropes in the 48 versus the 24 hours group measured by cumulative vasopressor index in the period from T0 to T72.
- Conditions
- Cardiac Arrest, Hypothermia
- Being tested
- Mild therapeutic hypothermia
- Keywords
- Cardiac arrest, Therapeutic Hypothermia, Cardioprotectiveness, Hemodynamics
- Medical subject headings
- Heart Arrest, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mild therapeutic hypothermiaProcedure or surgery
Mild therapeutic hypothermia with a target temperature between 32-34°C.
| Study group | Role | What they receive |
|---|---|---|
| 24 hours mild therapeutic hypothermia | Active comparator | The patient will be treated with mild therapeutic hypothermia for 24 hours after reaching the target temperature between 32-34°C. Receives: Procedure: Mild therapeutic hypothermia |
| 48 hours mild therapeutic hypothermia | Experimental | The patient will be treated with mild therapeutic hypothermia for 48 hours after reaching the target temperature between 32-34°C. Receives: Procedure: Mild therapeutic hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve cTnT
Allocated sub study 1
Measured: In the intervention period from 24 to 72 hours
Mitral annular systolic velocity
Allocated sub study 2
Measured: After 24 hours, 48 hours and 72 hours
Duration of arrhythmias
Allocated sub study 3
Measured: From target temperature (32-34°C) has been reached until 72 hours after
Cumulative vasopressor index
Allocated sub study 3
Measured: From target temperature (32-34°C) has been reached until 72 hours after
Secondary outcomes (1)
Area under the curve NT-proBNP
Allocated sub study 1
Measured: In the intervention period from 24 to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startFeb 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anders Grejs, MD, Principal investigator, Research Center of Emergency Medicine and Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Skejby, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066753
- Sponsor's protocol ID
- TTH48AG
- Status last verified
- Nov 2015
- First submitted
- 17 Feb 2014
- Last updated
- 25 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Jensen TH, Juhl-Olsen P, Nielsen BRR, Heiberg J, Duez CHV, Jeppesen AN, Frederiksen CA, Kirkegaard H, Grejs AM. Echocardiographic parameters during prolonged targeted temperature Management in out-of-hospital Cardiac Arrest Survivors to predict neurological outcome - a post-hoc analysis of the TTH48 trial. Scand J Trauma Resusc Emerg Med. 2021 Feb 19;29(1):37. doi: 10.1186/s13049-021-00849-7.
PubMed 33608045Grejs AM, Nielsen BRR, Juhl-Olsen P, Gjedsted J, Sloth E, Heiberg J, Frederiksen CA, Jeppesen AN, Duez CHV, Hamre PD, Soreide E, Kirkegaard H. Effect of prolonged targeted temperature management on left ventricular myocardial function after out-of-hospital cardiac arrest - A randomised, controlled trial. Resuscitation. 2017 Jun;115:23-31. doi: 10.1016/j.resuscitation.2017.03.021. Epub 2017 Apr 2.
PubMed 28377297
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cardiac Effects of Prolonged Hypothermia After Cardiac Arrest
- ClinicalTrials.gov ID
- NCT02066753
- Acronym / sponsor ID
- TTH48AG
- Conditions
- Cardiac Arrest, Hypothermia
- Keywords
- Cardiac arrest, Therapeutic Hypothermia, Cardioprotectiveness, Hemodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 19 Feb 2014 (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.
This PhD study is a sub study in a randomized clinical controlled multicenter trial named "TTH48" (ClinicalTrials.gov Identifier: NCT01689077).
The TTH48 trial examines prolonged mild therapeutic hypothermia ("MTH") at 32-34°C in 24 versus 48 hours with the primary outcome Cerebral Performance Category after 6 month in comatose out-of-hospital cardiac arrest patients.
THE OVERALL AIM OF THIS PhD STUDY IS TO INVESTIGATE THE CARDIAC FUNCTION AND THE HEMODYNAMICS BY BIOCHEMICAL CARDIAC MARKERS, ECHOCARDIOGRAPHY, BY ANALYZING THE USAGE OF INOTROPES/VASOPRESSORS AND BY ANALYZING ECG DATA FOR ARRHYTHMIAS IN THE 24 VERSUS 48 HOURS MTH GROUPS.
Detailed description
The PhD-study contains 3 sub studies:
- Study 1 estimates the extend of myocardial damage resulting from the primary arrest and from the reperfusion injuries: Area under the curve of cTnT and CK-MB as 12 repeated measurements and NT-proBNP as 4 measurements post arrest -Hypothesis: There is a statistically significantly greater release of the cardiac biomarkers cTnT and NT-proBNP quantified by the area under the curve in the 24 versus the 48 hours group in the intervention period from 24 to 72 hours.
- Study 2 investigates MTH´s influence on systolic and diastolic function by standard and Tissue Doppler (TDI) echocardiography after 24, 48 and 72 hours. The primary endpoint is mitral annular systolic velocity ("S´ max") -Primary hypothesis: There is statistically significant improvement in S' max from the time T24 to T72 in the 48 versus the 24 hours group. -Secondary hypothesis: There is statistically significantly better systolic function at T48 measured in terms of individual S' max-change in the 48 hours group (still hypothermic) versus the 24 hours group (reached normothermia).
- Study 3 investigates MTH´s influence on the need for vasopressor or inotrope and the duration of arrhythmias during the first 72 hours post arrest.
- Primary hypothesis: There is a statistically significantly increased tendency of arrhythmias in the 48 versus the 24 hours group measured in the period from T0 to T72.
- Secondary hypothesis: There is a statistically significantly reduced need for inotropes in the 48 versus the 24 hours group measured by cumulative vasopressor index in the period from T0 to T72.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 24 hours mild therapeutic hypothermia | Active comparator | Procedure: Mild therapeutic hypothermiaThe patient will be treated with mild therapeutic hypothermia for 24 hours after reaching the target temperature between 32-34°C. |
| 48 hours mild therapeutic hypothermia | Experimental | Procedure: Mild therapeutic hypothermiaThe patient will be treated with mild therapeutic hypothermia for 48 hours after reaching the target temperature between 32-34°C. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Resuscitated after cardiac arrest outside hospital with suspected cardiac triggering cause (and stabile circulation for at least 20 minutes after return of spontaneous circulation,
- Glasgow coma score < 8 and
- Age ≥ 18 years and < 80 years.
Key exclusion criteria (15 listed)
- Cardiac arrest of suspected non-cardiac triggering cause (e.g. trauma, aortic dissection, massive bleeding, hypoxia or accidental hypothermia),
- >60 minutes from cardiac arrest to ROSC,
- Time from cardiac arrest until start of cooling >4 hours,
- Terminal illness,
- Coagulopathy (medical anticoagulation treatment including thrombolysis is not a contraindication),
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 |
|---|---|---|
| Mild therapeutic hypothermiaMild therapeutic hypothermia with a target temperature between 32-34°C. | Procedure or surgery | 24 hours mild therapeutic hypothermia, 48 hours mild therapeutic hypothermia |
Primary outcome
Area under the curve cTnT
Time frame: In the intervention period from 24 to 72 hours
Allocated sub study 1
Mitral annular systolic velocity
Time frame: After 24 hours, 48 hours and 72 hours
Allocated sub study 2
Duration of arrhythmias
Time frame: From target temperature (32-34°C) has been reached until 72 hours after
Allocated sub study 3
Cumulative vasopressor index
Time frame: From target temperature (32-34°C) has been reached until 72 hours after
Allocated sub study 3
1 secondary outcome
Area under the curve NT-proBNP
Time frame: In the intervention period from 24 to 72 hours
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 25 Nov 2015.
- Derived from this study: PubMed 33608045Jensen TH, Juhl-Olsen P, Nielsen BRR, Heiberg J, Duez CHV, Jeppesen AN, Frederiksen CA, Kirkegaard H, Grejs AM. Echocardiographic parameters during prolonged targeted temperature Management in out-of-hospital Cardiac Arrest Survivors to predict neurological outcome - a post-hoc analysis of the TTH48 trial. Scand J Trauma Resusc Emerg Med. 2021 Feb 19;29(1):37. doi: 10.1186/s13049-021-00849-7.
- Derived from this study: PubMed 28377297Grejs AM, Nielsen BRR, Juhl-Olsen P, Gjedsted J, Sloth E, Heiberg J, Frederiksen CA, Jeppesen AN, Duez CHV, Hamre PD, Soreide E, Kirkegaard H. Effect of prolonged targeted temperature management on left ventricular myocardial function after out-of-hospital cardiac arrest - A randomised, controlled trial. Resuscitation. 2017 Jun;115:23-31. doi: 10.1016/j.resuscitation.2017.03.021. Epub 2017 Apr 2.
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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.
Anders Grejs, MD principal investigator
Research Center of Emergency Medicine and Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Skejby, Denmark
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mild therapeutic hypothermia in people with Cardiac Arrest and Hypothermia, run by University of Aarhus at 2 sites in 2 countries.
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 3 inclusion and 15 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 25 Nov 2015. 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 Denmark, Norway. 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?
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?
Area under the curve cTnT (time frame: In the intervention period from 24 to 72 hours). The study lists 4 primary outcomes in all. 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 NCT02066753, which also lists 2 linked publications.
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 25 Nov 2015.