The Current Status and Clinical OUTcomes of Cardiogenic Shock Patients And the Role of Specialist in Cardiovascular Critical Care Unit
SCOUT SPARC
1 other identifier
observational
10,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
June 1, 2022
CompletedFirst Posted
Study publicly available on registry
June 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2030
June 13, 2022
June 1, 2022
9.9 years
June 1, 2022
June 8, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
In-hospital death
Death during hospitlization
30 days after onset of cardiogenic shock
Secondary Outcomes (7)
In-hospital cardiac death
30 days after onset of cardiogenic shock
Defective neurological indicators
30 days after onset of cardiogenic shock
cardiac death within 30 days
30 days after onset of cardiogenic shock
all cause of death within 30 days
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.
- +2 more secondary outcomes
Study Arms (2)
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.
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.
Eligibility Criteria
(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.
You may qualify if:
- (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.
- ) 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.
- ) 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.
- ) Patients supported by Mechanical Circulatory support device
- Where the cause of a cardiogenic shock conforms to one or more of the following matters:
- ) 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.
- ) In the case of an intervention or surgery has been performed due to valve disease.
- ) In the case of the insertion of an instrument in the heart is performed due to atrial defect, left atrium, arteriosclerosis, etc.
- ) In the case of ablation or surgery, defibrillator implantation, and pacemaker implantation.
- ) In the case of pericardiocentesis or window formation has been performed due to cardiac tamponade.
- ) When monitoring is required for hypothermia therapy after spontaneous circulation recovery.
- ) 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
- +1 more criteria
You may not qualify if:
- A patient with irreparable brain damage.
- If there are no witnesses outside the hospital during cardiac arrest.
- DNR(Do Not Resuscitate) patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yonsei University Health System, Severance Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chul-Min Ahn
Yonsei University Health system Severance Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2022
First Posted
June 13, 2022
Study Start
June 1, 2020
Primary Completion (Estimated)
May 1, 2030
Study Completion (Estimated)
May 1, 2030
Last Updated
June 13, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share