The Current Status and Clinical OUTcomes of Cardiogenic Shock Patients And the Role of Specialist in Cardiovascular Critical Care Unit
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cardiogenic Shock. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- In-hospital death [Time frame: 30 days after onset of cardiogenic shock]
Secondary outcome measures (7)
- In-hospital cardiac death [Time frame: 30 days after onset of cardiogenic shock]
- Defective neurological indicators [Time frame: 30 days after onset of cardiogenic shock]
- cardiac death within 30 days [Time frame: 30 days after onset of cardiogenic shock]
- all cause of death within 30 days [Time frame: 30 days after onset of cardiogenic shock]
- all cause of death during follow-up [Time frame: 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.]
- Major Adverse Cardiovascular Events during follow-up [Time frame: 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 [Time frame: 30 days after onset of cardiogenic shock]
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.
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
- 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
- A patient with irreparable brain damage.
- If there are no witnesses outside the hospital during cardiac arrest.
- DNR(Do Not Resuscitate) patients
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Yonsei University Health System, Severance Hospital — Seoul
Identifiers
NCT: NCT05415332 · 4-2020-0383