Clinical trial NCT05415332: The Current Status and Clinical OUTcomes of Cardiogenic Shock Patients And the Role of Specialist in Cardiovascular Critical Care Unit
Official title: The Current Status and Clinical OUTcomes of Cardiogenic Shock Patients And the Role of Specialist in Cardiovascular Critical Care Unit
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiogenic Shock
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 10000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: (prospective) Patients over 19-year-old who have been hospitalized in cardiovascular critical care unit for cardiogenic shock and other causes of decreased blood pressure after the IRB approval date.

(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.

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.


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

Primary outcomes:
measure: In-hospital death
timeFrame: 30 days after onset of cardiogenic shock
Secondary outcomes:
measure: In-hospital cardiac death
timeFrame: 30 days after onset of cardiogenic shock
measure: Defective neurological indicators
timeFrame: 30 days after onset of cardiogenic shock
measure: cardiac death within 30 days
timeFrame: 30 days after onset of cardiogenic shock
measure: all cause of death within 30 days
timeFrame: 30 days after onset of cardiogenic shock
measure: all cause of death during follow-up
timeFrame: 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.
measure: Major Adverse Cardiovascular Events during follow-up
timeFrame: 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.
measure: successful weaning of mechanical circulatory support device
timeFrame: 30 days after onset of cardiogenic shock
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Yonsei University Health system Severance Hospital
name: Chul-Min Ahn
role: PRINCIPAL_INVESTIGATOR
References: