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

NCT ID: NCT05415332

Last Updated: 2022-06-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2030-05-31

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.

Conditions

Cardiogenic Shock

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Cardiogenic shock patients

We will collect patient's demographic information, medical history, vital signs, cardiac arrest, the maximum dose of the drug at shock treatment and whether mechanical circulatory support devices are inserted, indicators of deterioration and improvement of shock.

For follow-up observations, only prospective subjects are examined for results and administrative information conducted by visiting an outpatient at the time of one, six, one, two, three, four, and five or more years after the shock.

No interventions assigned to this group

Patients hospitalized in cardiovascular intensive care unit

we will collect patient's demographic information, medical history related to cardiovascular disease, and vital signs on the admission date to the cardiovascular critical care unit.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

(prospective)

1. Patients over 19-year-old

2. 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

3. 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.

3-4) In the case of ablation or surgery, defibrillator implantation, and pacemaker implantation.

3-5) In the case of pericardiocentesis or window formation has been performed due to cardiac tamponade.

3-6) When monitoring is required for hypothermia therapy after spontaneous circulation recovery.

3-7) When monitoring is required after other heart-related procedures or surgery 3-8) When monitoring is required after heart transplant

4. Where a patient or legal representative voluntarily agrees to access medical records and data necessary for this study during the entire study period

(retrospective) Patients over 19-year-old who treated in the cardiovascular critical care unit from January 1, 2018 to the IRB approval date for decreased blood pressure or needed intensive monitoring of vital signs.

Exclusion Criteria

1. A patient with irreparable brain damage.

2. If there are no witnesses outside the hospital during cardiac arrest.

3. DNR(Do Not Resuscitate) patients

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chul-Min Ahn

Role: PRINCIPAL_INVESTIGATOR

Yonsei University Health system Severance Hospital

Locations

Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Chul-Min Ahn

Role: CONTACT

drcello@yuhs.ac

+82-2-2228-8326

Facility Contacts

Chul-Min Ahn

Role: primary

drcello@yuhs.ac

+82-2-2228-8326

Other Identifiers

4-2020-0383

Identifier Type: -

Identifier Source: org_study_id