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

July 28, 2019 updated by: China Medical University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

141

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan
        • China Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days after enrollment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interleukin-6 - the Plasma Level of Participants
Time Frame: between 6 and 24 hours after enrollment.
IL-6 level change
between 6 and 24 hours after enrollment.
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
between 6 and 24 hours after enrollment
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
between 6 and 24 hours after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

  • Study Director: Da-Long Chen, Master, Chnia Medical University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

August 18, 2018

Study Completion (Actual)

August 18, 2018

Study Registration Dates

First Submitted

December 8, 2015

First Submitted That Met QC Criteria

December 14, 2015

First Posted (Estimate)

December 17, 2015

Study Record Updates

Last Update Posted (Actual)

August 7, 2019

Last Update Submitted That Met QC Criteria

July 28, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH104-REC3-058

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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