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NCT Number: NCT05415332

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

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.

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Key information

Conditions

Cardiogenic Shock Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Chul-Min Ahn

CONTACT

[email protected]

+82-2-2228-8326

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. In-hospital death

    Time frame: 30 days after onset of cardiogenic shock

    Death during hospitlization

Secondary outcomes

  1. In-hospital cardiac death

    Time frame: 30 days after onset of cardiogenic shock

    cardiac death during hospitlization

  2. Defective neurological indicators

    Time frame: 30 days after onset of cardiogenic shock

    Measurement using CPC(Cerebral perfomance category) score

  3. cardiac death within 30 days

    Time frame: 30 days after onset of cardiogenic shock

    30 Days mortality

  4. all cause of death within 30 days

    Time frame: 30 days after onset of cardiogenic shock

    30 Days mortality

  5. 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.

    all cause of death during follow-up

  6. 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.

    Major Adverse Cardiovascular events(MACE) is defined CVD events, admission for heart failure, ischemic cardiovascular events, bleeding events, cardiac death, heart transplactation, other thromboembolism

  7. successful weaning of mechanical circulatory support device

    Time frame: 30 days after onset of cardiogenic shock

    if successful weaning of mechanical circulatory support device or not

Study contacts

Contact information is provided by the study sponsor or research team.

Chul-Min Ahn

CONTACT

[email protected]

+82-2-2228-8326

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Acronym: SCOUT SPARC

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Jun 13, 2022
Registry last updated
Jun 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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