Understanding outcomes in patients with cardiogenic shock

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

This study looks at how different treatments and support devices can help people with cardiogenic shock feel better and improve their chances of recovery.

Quick facts

• Study type: Observational
• Enrollment: 10000 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Yonsei University (Academic / other)
• Locations: 1 site (Seoul)
• Trial ID: NCT05415332 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the treatment status and clinical outcomes of patients experiencing cardiogenic shock in a cardiovascular critical care unit. It will analyze both prospective and retrospective data to identify factors that may improve patient prognosis, including various drug treatments and the use of mechanical circulatory support devices. The study seeks to fill the gap in existing literature regarding hemodynamic monitoring and the overall management of cardiogenic shock, particularly beyond cases related to myocardial infarction.

Who should consider this trial

Good fit: Ideal candidates include hospitalized patients over 19 years old with cardiogenic shock or significantly reduced blood pressure.

Not a fit: Patients with cardiogenic shock not requiring hospitalization or those under 19 years old may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment protocols and better outcomes for patients suffering from cardiogenic shock.

How similar studies have performed: While there is limited research specifically on cardiogenic shock, studies on hemodynamic monitoring and mechanical support devices have shown promise in improving patient outcomes.

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

Where this trial is running

Seoul

• Yonsei University Health System, Severance Hospital — Seoul, South Korea (Recruiting)

Study contacts

• Principal investigator: Chul-Min Ahn — Yonsei University Health System, Severance Hospital
• Study coordinator: Chul-Min Ahn

Conditions Cardiogenic Shock