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Clinical Trials/NCT05415332
NCT05415332
Recruiting
N/A

The Current Status and Clinical OUTcomes of Cardiogenic Shock Patients And the Role of Specialist in Cardiovascular Critical Care Unit

Yonsei University1 site in 1 country10,000 target enrollmentJune 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cardiogenic Shock
Sponsor
Yonsei University
Enrollment
10000
Locations
1
Primary Endpoint
In-hospital death
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

In the case of cardiogenic shock, the early mortality rate is the highest compared to other types of shock, but it is characterized by a good prognosis and quality of life after recovery, so monitoring the treatment progress is very important to identify the patient's prognosis. However, there are few studies specifically reported on hemodynamic monitoring and prognosis of cardiogenic shock. In addition, as mechanical circulatory support devices are in the spotlight, studies on their effects and safety are starting, but studies on cardiogenic shock are often limited to patients with myocardial infarction.

This study is a prospective and retrospective cohort observational study, we aim to identify factors that can improve prognosis, including various drug treatments, diagnostic techniques, and mechanical circulatory support device by investigating the treatment status and clinical outcomes of patients with cardiogenic shock hospitalized in cardiovascular critical care unit. In addition, the purpose of this study is to investigate the association between the prognosis of patients with cardiogenic shock and the presence of a specialist resident during regular work hours to clarify the role and necessity of a resident specialist in the cardiovascular intensive care unit.

Furthermore, by predicting and treating the clinical course of patients with cardiogenic shock at an early stage, the aim is to reduce the mortality rate and improve the patients' ability to perform daily activities.

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
May 2030
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • (prospective)
  • Patients over 19-year-old
  • Patients who are hospitalized in the cardiovascular critical care unit for cardiogenic shock or reduced blood pressure due to other causes.
  • 2-1) In the event that the systolic blood pressure is less than 90mmHg for at least 30 minutes despite fluid treatment, or the use of vasopressor drug is required to maintain systolic blood pressure more than 90mmHg.
  • 2-2) patients have at least one of the symptoms of peripheral tissue hypoperfusion (cold skin, urineoutput \< 30cc/ hour, decreased consciousness, lactate \> 2.0mmol/l) or pulmonary edema.
  • 2-3) Patients supported by Mechanical Circulatory support device
  • Where the cause of a cardiogenic shock conforms to one or more of the following matters:
  • 3-1) In the case of an intervention or surgery has been performed due to coronary artery disease, peripheral artery disease, venous thromboembolism, pulmonary artery disease, aortic disease, etc.
  • 3-2) In the case of an intervention or surgery has been performed due to valve disease.
  • 3-3) In the case of the insertion of an instrument in the heart is performed due to atrial defect, left atrium, arteriosclerosis, etc.

Exclusion Criteria

  • A patient with irreparable brain damage.
  • If there are no witnesses outside the hospital during cardiac arrest.
  • DNR(Do Not Resuscitate) patients

Outcomes

Primary Outcomes

In-hospital death

Time Frame: 30 days after onset of cardiogenic shock

Death during hospitlization

Secondary Outcomes

  • Defective neurological indicators(30 days after onset of cardiogenic shock)
  • cardiac death within 30 days(30 days after onset of cardiogenic shock)
  • Major Adverse Cardiovascular Events during follow-up(Outpatient visits at the time of one month, six months, one year, two years, three years, four years and five years from the date of the cardiogenic shock.)
  • In-hospital cardiac death(30 days after onset of cardiogenic shock)
  • all cause of death during follow-up(Outpatient visits at the time of one month, six months, one year, two years, three years, four years and five years from the date of the cardiogenic shock.)
  • successful weaning of mechanical circulatory support device(30 days after onset of cardiogenic shock)
  • all cause of death within 30 days(30 days after onset of cardiogenic shock)

Study Sites (1)

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