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

Cardiogenic Shock Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05415332
• Other study ID #: 4-2020-0383
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: May 2030

Study information

• Verified date: June 2022
• Source: Yonsei University
• Contact: Chul-Min Ahn
• Phone: +82-2-2228-8326
• Email: drcello[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: May 2030
• Est. primary completion date: May 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock
• Shock, Cardiogenic

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital death	Death during hospitlization	30 days after onset of cardiogenic shock
Secondary	In-hospital cardiac death	cardiac death during hospitlization	30 days after onset of cardiogenic shock
Secondary	Defective neurological indicators	Measurement using CPC(Cerebral perfomance category) score	30 days after onset of cardiogenic shock
Secondary	cardiac death within 30 days	30 Days mortality	30 days after onset of cardiogenic shock
Secondary	all cause of death within 30 days	30 Days mortality	30 days after onset of cardiogenic shock
Secondary	all cause of death during follow-up	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.
Secondary	Major Adverse Cardiovascular Events during follow-up	Major Adverse Cardiovascular events(MACE) is defined CVD events, admission for heart failure, ischemic cardiovascular events, bleeding events, cardiac death, heart transplactation, other thromboembolism	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.
Secondary	successful weaning of mechanical circulatory support device	if successful weaning of mechanical circulatory support device or not	30 days after onset of cardiogenic shock