Cardiac ArrestNCT02633358
Anti-inflammatory Effect of Therapeutic Hypothermia in Out-hospital Cardiac Arrest Patients With Cardiogenic Shock
A study testing Therapeutic hypothermia group in people with Cardiac Arrest, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Acute myocardial infarction complicated with cardiogenic shock trigger IL-6, the strong inflammatory response, result in multiple organ failure, even death. While therapeutic hypothermia,to expect the possibility of anti-inflammatory effect via IL-6 bi-phasic effect and IL-10 , to improve the multiple organ failure… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Therapeutic hypothermia group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2015to 18 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18-100 years
- Cardiogenic sock including initial lactate level >18 mg/dL, necessary of vasopressor to keep mean artery pressure >65mmHg after adequate fluid supply, and signs of reduced cardiac output including disturbance consciousness, cold limbs, decreased urine output, acute pulmonary congestion and so on.
Who cannot join
- Patient or family refuse
- Metastatic cancer
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anti-inflammatory Effect of Therapeutic Hypothermia in Out-hospital Cardiac Arrest Patients With Cardiogenic Shock Via Interleukin-6 Trans-signaling
Acute myocardial infarction complicated with cardiogenic shock trigger IL-6, the strong inflammatory response, result in multiple organ failure, even death.
While therapeutic hypothermia,to expect the possibility of anti-inflammatory effect via IL-6 bi-phasic effect and IL-10 , to improve the multiple organ failure, to increase survival rate and well cerebral performance.
Read the detailed description
Despite emergency coronary revascularization coupled with medical stabilization, intra-aortic balloon pump have significantly improved survival in patients with cardiogenic shock complicating acute myocardial infarction, mortality still remains excessively high, being actually about 30-50%. Future research should focus on new therapeutic strategies, aimed to further decrease mortality rate of these patients or improve possible hospitalization and prognosis.
Heart pumping failure result in cardiogenic shock. Increased LA filling pressure result in acute pulmonary edema, hypoxemic respiratory failure, even congestive kidney and congestive liver. Decreased stroke volume result in hypoperfusion obviously direct induce acute renal failure, disturbance consciousness and lactate accumulation, even, shock liver. Multiple organ failure is the major mortality in the patients suffered from cardiogenic shock after acute myocardial infarction.
Cardiogenic shock remains the leading cause of death in patients hospitalized for myocardial infarction . Systemic inflammation , especially endovascular Interleukin-6, triggered by Tumor necrosis factor-alfa and Interleukin-1 beta result in inappropriate vasodilatation is observed in many patients with cardiogenic shock and may contribute to an excess mortality rate. In recent study, interleukin-6 represented a reliable independent early prognostic marker of 30-day mortality.
Therapeutic hypothermia (34℃) increase stroke volume, reduce muscle oxygen consumption and enhance anti-inflammatory action . The mechanism of anti-inflammatory effect for therapeutic hypothermia in cardiogenic shock is still unclear, need to further study in clinical trial. Furthermore, this study will provide new strategy to increase survival rate in cardiogenic shock.
- Conditions
- Cardiac Arrest
- Being tested
- Therapeutic hypothermia group
- Keywords
- Acute myocardial infarction, cardiogenic shock
- Medical subject headings
- Heart Arrest, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic hypothermia groupDevice
Therapeutic hypothermia
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic hypothermia group | Experimental | Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling Receives: Device: Therapeutic hypothermia group |
| Control group | No intervention | No therapeutic hypothermia for controlled data. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Rate - Number of Participants Alive
Survival rate according to the number of participants alive in the 90 days after enrollment.
Measured: 90 days after enrollment
Secondary outcomes (1)
Neurologic Outcome - Number of Participants
Neurological outcome according to Cerebral performance Category scales: scales 1-2 in favor of favorable neurological outcome; scales 3-5 in favor of poor neurological outcome including severe cerebral disability, coma or vegetative state, brain death.
Measured: 90 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study start1 Nov 2015
- Primary completion18 Aug 2018
- Study completion18 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)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 China Medical University HospitalThe 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
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Da-Long Chen, Master, Study director, Chnia Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633358
- Sponsor's protocol ID
- CMUH104-REC3-058
- Status last verified
- Jul 2019
- First submitted
- 8 Dec 2015
- Last updated
- 7 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Schmitt KR, Tong G, Berger F. Mechanisms of hypothermia-induced cell protection in the brain. Mol Cell Pediatr. 2014 Dec;1(1):7. doi: 10.1186/s40348-014-0007-x. Epub 2014 Dec 1.
PubMed 26567101Bro-Jeppesen J, Kjaergaard J, Stammet P, Wise MP, Hovdenes J, Aneman A, Horn J, Devaux Y, Erlinge D, Gasche Y, Wanscher M, Cronberg T, Friberg H, Wetterslev J, Pellis T, Kuiper M, Nielsen N, Hassager C; TTM-Trial Investigators. Predictive value of interleukin-6 in post-cardiac arrest patients treated with targeted temperature management at 33 degrees C or 36 degrees C. Resuscitation. 2016 Jan;98:1-8. doi: 10.1016/j.resuscitation.2015.10.009. Epub 2015 Oct 23.
PubMed 26525271Forkmann M, Kolschmann S, Holzhauser L, Ibrahim K, Guenther M, Christoph M, Fuhrmann JT, Boscheri A, Schmeibetaer A, Strasser RH, Wunderlich C. Target temperature management of 33 degrees C exerts beneficial haemodynamic effects after out-of-hospital cardiac arrest. Acta Cardiol. 2015 Aug;70(4):451-9. doi: 10.1080/ac.70.4.3096893.
PubMed 26455248Nobile L, Lamanna I, Fontana V, Donadello K, Dell'anna AM, Creteur J, Vincent JL, Pappalardo F, Taccone FS. Greater temperature variability is not associated with a worse neurological outcome after cardiac arrest. Resuscitation. 2015 Nov;96:268-74. doi: 10.1016/j.resuscitation.2015.09.004. Epub 2015 Sep 16.
PubMed 26386374Bro-Jeppesen J, Kjaergaard J, Wanscher M, Nielsen N, Friberg H, Bjerre M, Hassager C. Systemic Inflammatory Response and Potential Prognostic Implications After Out-of-Hospital Cardiac Arrest: A Substudy of the Target Temperature Management Trial. Crit Care Med. 2015 Jun;43(6):1223-32. doi: 10.1097/CCM.0000000000000937.
PubMed 25756419Dankiewicz J, Nielsen N, Annborn M, Cronberg T, Erlinge D, Gasche Y, Hassager C, Kjaergaard J, Pellis T, Friberg H. Survival in patients without acute ST elevation after cardiac arrest and association with early coronary angiography: a post hoc analysis from the TTM trial. Intensive Care Med. 2015 May;41(5):856-64. doi: 10.1007/s00134-015-3735-z. Epub 2015 Mar 24.
PubMed 25800582Chen D, Lin Y, Ko P, Lin J, Huang C, Wang G, Chang KC. Effect of targeted temperature management on systemic inflammatory responses after out-of-hospital cardiac arrest: A prospective cohort study. Medicine (Baltimore). 2024 Sep 20;103(38):e39780. doi: 10.1097/MD.0000000000039780.
PubMed 39312301Chen DL, Chung CM, Wang GJ, Chang KC. Lactate-to-albumin ratio and cholesterol levels predict neurological outcome in cardiac arrest survivors. Am J Emerg Med. 2024 Sep;83:9-15. doi: 10.1016/j.ajem.2024.06.029. Epub 2024 Jun 25.
PubMed 38943710
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-inflammatory Effect of Therapeutic Hypothermia in Out-hospital Cardiac Arrest Patients With Cardiogenic Shock Via Interleukin-6 Trans-signaling
- ClinicalTrials.gov ID
- NCT02633358
- Acronym / sponsor ID
- CMUH104-REC3-058
- Conditions
- Cardiac Arrest
- Keywords
- Acute myocardial infarction, cardiogenic shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2015
- Primary completion
- 18 Aug 2018 (actual)
- Study completion
- 18 Aug 2018 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Posted 23 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute myocardial infarction complicated with cardiogenic shock trigger IL-6, the strong inflammatory response, result in multiple organ failure, even death.
While therapeutic hypothermia,to expect the possibility of anti-inflammatory effect via IL-6 bi-phasic effect and IL-10 , to improve the multiple organ failure, to increase survival rate and well cerebral performance.
Detailed description
Despite emergency coronary revascularization coupled with medical stabilization, intra-aortic balloon pump have significantly improved survival in patients with cardiogenic shock complicating acute myocardial infarction, mortality still remains excessively high, being actually about 30-50%. Future research should focus on new therapeutic strategies, aimed to further decrease mortality rate of these patients or improve possible hospitalization and prognosis.
Heart pumping failure result in cardiogenic shock. Increased LA filling pressure result in acute pulmonary edema, hypoxemic respiratory failure, even congestive kidney and congestive liver. Decreased stroke volume result in hypoperfusion obviously direct induce acute renal failure, disturbance consciousness and lactate accumulation, even, shock liver. Multiple organ failure is the major mortality in the patients suffered from cardiogenic shock after acute myocardial infarction.
Cardiogenic shock remains the leading cause of death in patients hospitalized for myocardial infarction . Systemic inflammation , especially endovascular Interleukin-6, triggered by Tumor necrosis factor-alfa and Interleukin-1 beta result in inappropriate vasodilatation is observed in many patients with cardiogenic shock and may contribute to an excess mortality rate. In recent study, interleukin-6 represented a reliable independent early prognostic marker of 30-day mortality.
Therapeutic hypothermia (34℃) increase stroke volume, reduce muscle oxygen consumption and enhance anti-inflammatory action . The mechanism of anti-inflammatory effect for therapeutic hypothermia in cardiogenic shock is still unclear, need to further study in clinical trial. Furthermore, this study will provide new strategy to increase survival rate in cardiogenic shock.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic hypothermia group | Experimental | Device: Therapeutic hypothermia groupAnti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling |
| Control group | No intervention | –No therapeutic hypothermia for controlled data. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18-100 years
- Cardiogenic sock including initial lactate level >18 mg/dL, necessary of vasopressor to keep mean artery pressure >65mmHg after adequate fluid supply, and signs of reduced cardiac output including disturbance consciousness, cold limbs, decreased urine output, acute pulmonary congestion and so on.
Key exclusion criteria (3 listed)
- Patient or family refuse
- Metastatic cancer
- Pregnancy
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 |
|---|---|---|
| Therapeutic hypothermia groupTherapeutic hypothermia | Device | Therapeutic hypothermia group |
Primary outcome
Survival Rate - Number of Participants Alive
Time frame: 90 days after enrollment
Survival rate according to the number of participants alive in the 90 days after enrollment.
1 secondary outcome
Neurologic Outcome - Number of Participants
Time frame: 90 days after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26567101Schmitt KR, Tong G, Berger F. Mechanisms of hypothermia-induced cell protection in the brain. Mol Cell Pediatr. 2014 Dec;1(1):7. doi: 10.1186/s40348-014-0007-x. Epub 2014 Dec 1.
- Background: PubMed 26525271Bro-Jeppesen J, Kjaergaard J, Stammet P, Wise MP, Hovdenes J, Aneman A, Horn J, Devaux Y, Erlinge D, Gasche Y, Wanscher M, Cronberg T, Friberg H, Wetterslev J, Pellis T, Kuiper M, Nielsen N, Hassager C; TTM-Trial Investigators. Predictive value of interleukin-6 in post-cardiac arrest patients treated with targeted temperature management at 33 degrees C or 36 degrees C. Resuscitation. 2016 Jan;98:1-8. doi: 10.1016/j.resuscitation.2015.10.009. Epub 2015 Oct 23.
- Background: PubMed 26455248Forkmann M, Kolschmann S, Holzhauser L, Ibrahim K, Guenther M, Christoph M, Fuhrmann JT, Boscheri A, Schmeibetaer A, Strasser RH, Wunderlich C. Target temperature management of 33 degrees C exerts beneficial haemodynamic effects after out-of-hospital cardiac arrest. Acta Cardiol. 2015 Aug;70(4):451-9. doi: 10.1080/ac.70.4.3096893.
- Background: PubMed 26386374Nobile L, Lamanna I, Fontana V, Donadello K, Dell'anna AM, Creteur J, Vincent JL, Pappalardo F, Taccone FS. Greater temperature variability is not associated with a worse neurological outcome after cardiac arrest. Resuscitation. 2015 Nov;96:268-74. doi: 10.1016/j.resuscitation.2015.09.004. Epub 2015 Sep 16.
- Background: PubMed 25756419Bro-Jeppesen J, Kjaergaard J, Wanscher M, Nielsen N, Friberg H, Bjerre M, Hassager C. Systemic Inflammatory Response and Potential Prognostic Implications After Out-of-Hospital Cardiac Arrest: A Substudy of the Target Temperature Management Trial. Crit Care Med. 2015 Jun;43(6):1223-32. doi: 10.1097/CCM.0000000000000937.
- Background: PubMed 25800582Dankiewicz J, Nielsen N, Annborn M, Cronberg T, Erlinge D, Gasche Y, Hassager C, Kjaergaard J, Pellis T, Friberg H. Survival in patients without acute ST elevation after cardiac arrest and association with early coronary angiography: a post hoc analysis from the TTM trial. Intensive Care Med. 2015 May;41(5):856-64. doi: 10.1007/s00134-015-3735-z. Epub 2015 Mar 24.
- Derived from this study: PubMed 39312301Chen D, Lin Y, Ko P, Lin J, Huang C, Wang G, Chang KC. Effect of targeted temperature management on systemic inflammatory responses after out-of-hospital cardiac arrest: A prospective cohort study. Medicine (Baltimore). 2024 Sep 20;103(38):e39780. doi: 10.1097/MD.0000000000039780.
- Derived from this study: PubMed 38943710Chen DL, Chung CM, Wang GJ, Chang KC. Lactate-to-albumin ratio and cholesterol levels predict neurological outcome in cardiac arrest survivors. Am J Emerg Med. 2024 Sep;83:9-15. doi: 10.1016/j.ajem.2024.06.029. Epub 2024 Jun 25.
- Individual participant dataSharing planned: No
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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.
Da-Long Chen, Master study director
Chnia Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic hypothermia group in people with Cardiac Arrest, run by China Medical University Hospital at 1 site in Taiwan.
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 3 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 7 Aug 2019. 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 Taiwan. 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?
Yes. Results are posted in the registry (first posted 23 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Rate - Number of Participants Alive (time frame: 90 days after enrollment). 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 NCT02633358, which also lists 8 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 7 Aug 2019.