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Anti-inflammatory Effect of Therapeutic Hypothermia in Out-hospital Cardiac Arrest Patients With Cardiogenic Shock

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ClinicalTrials.gov Identifier: NCT02633358
Recruitment Status : Completed
First Posted : December 17, 2015
Results First Posted : July 23, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

Brief 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, to increase survival rate and well cerebral performance.


Condition or disease Intervention/treatment Phase
Cardiac Arrest Device: Therapeutic hypothermia group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anti-inflammatory Effect of Therapeutic Hypothermia in Out-hospital Cardiac Arrest Patients With Cardiogenic Shock Via Interleukin-6 Trans-signaling
Study Start Date : November 1, 2015
Actual Primary Completion Date : August 18, 2018
Actual Study Completion Date : August 18, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Therapeutic hypothermia group
Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling
Device: Therapeutic hypothermia group
Therapeutic hypothermia

No Intervention: Control group
No therapeutic hypothermia for controlled data.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Neurologic Outcome - Number of Participants [ Time Frame: 90 days after enrollment ]
    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.


Other Outcome Measures:
  1. Interleukin-6 - the Plasma Level of Participants [ Time Frame: between 6 and 24 hours after enrollment. ]
    IL-6 level change

  2. Interleukin-6/Soluble Interleukin-6 Receptor Complex - the Plasma Level of Participants [ Time Frame: between 6 and 24 hours after enrollment ]
    Interleukin-6/soluble Interleukin-6 receptor complex plasma level hint the pro-inflammatory pathway via Interleukin-6 trans-signaling

  3. Soluble Interleukin-6 Receptor - the Plasma Level of Participants [ Time Frame: between 6 and 24 hours after enrollment ]
    Check the soluble Interleukin-6 plasma level at 6 hours and 24 hours after enrollment



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patient or family refuse
  • Metastatic cancer
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633358


Locations
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Taiwan
China Medical University Hospital
Taichung, Taiwan
Sponsors and Collaborators
China Medical University Hospital
Investigators
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Study Director: Da-Long Chen, Master Chnia Medical University Hospital
  Study Documents (Full-Text)

Documents provided by China Medical University Hospital:
Publications:

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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT02633358    
Other Study ID Numbers: CMUH104-REC3-058
First Posted: December 17, 2015    Key Record Dates
Results First Posted: July 23, 2019
Last Update Posted: August 7, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by China Medical University Hospital:
Acute myocardial infarction, cardiogenic shock
Additional relevant MeSH terms:
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Heart Arrest
Shock, Cardiogenic
Hypothermia
Shock
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Myocardial Infarction
Myocardial Ischemia
Vascular Diseases
Infarction
Ischemia
Necrosis