NCT05415332Recruiting
The Current Status and Clinical OUTcomes of Cardiogenic Shock Patients And the Role of Specialist in Cardiovascular Critical Care Unit
Source: ClinicalTrials.gov · Last updated 13 Jun 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 10000 (estimated)
- First submitted
- 1 Jun 2022
- Start date
- 1 Jun 2020
- Primary completion date
- 31 May 2030
- Lead sponsor
- Yonsei University
- NCT number
- NCT05415332
What you commit to
- Study type: Observational
- Planned participants: 10000
- From 1 Jun 2020 to the primary completion date, 31 May 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- If there are no witnesses outside the hospital during cardiac arrest.
Other
- A patient with irreparable brain damage.
- DNR(Do Not Resuscitate) patients
Who the study is looking for
- (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.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yonsei University Health System, Severance Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.