Clinical Outcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With Cardiogenic Shock

• Conditions: Shock, Cardiogenic

• Registration Number: NCT02985008
• Lead Sponsor: Jeong Hoon Yang

Brief Summary

Retrospectively and prospectively enrolled patients with cardiogenic shock in domestic manifolds and investigated the current state of treatment and clinical features of cardiogenic shock in Koreans and identified the factors that could improve the prognosis and the use of IABP and ECMO And to investigate its therapeutic effect.

Detailed Description

1. The selection / exclusion criteria for persons with cardiogenic shock should be verified by medical records from January 1, 2014 before the approval date of each institution's clinical trial screening committee.

2. If a cardiogenic shock to the selection criteria is found in the emergency room, general ward, or intensive care unit of the participating institutions, enroll in this study and fill in the information according to the e-CRF.

3. After 1, 6 and 12 months, visit the hospital for examination and procedures. The person in charge of the examination or the delegate of the examiner may follow the person by telephone or an outpatient visit.

Study Timeline

• Study Start: 2016-04
• Status Verified: 2016-12
• Study First Submitted: 2016-12-05
• Study First Submitted QC: 2016-12-05
• Last Update Submitted: 2016-12-05
• Study First Posted: 2016-12-07
• Last Update Posted: 2016-12-07
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. 19 years old or older

2. ① Systolic blood pressure is less than 90mmHg for more than 30 minutes despite the fluid therapy, or Use of pressure boosting agents is necessary.

   ② Peripheral hypopnea (cold skin, urine less than 30 cc per hour, impaired consciousness, lactate ≥2.0 mmol / l) or a person with pulmonary edema.

3. Causes of cardiogenic shock include acute myocardial infarction (including in coronary intervention), cardiomyopathy, myocarditis, pulmonary embolism, refractory ventricular tachycardia, shock during coronary intervention.

4. Those voluntarily consenting to the medical records and the data necessary for the study during the entire study period.

Exclusion Criteria

1. Other causes except for cardiogenic shock (low blood pressure, septic, obstructive shock)
2. Shock with cardiac arrest outside the hospital
3. People with allergic reactions to anticoagulants such as heparin.
4. Those who refused active treatment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In hospital death	for 1 year

Secondary Outcome Measures

Name	Time	Method
Death in 28days	28days
Death in 1 year	1 year
hospitalization days	1 year
Successful removal of left ventricular assist device (IABP, ECMO)	1 year
Death, myocardial infarction, stroke, re-admission due to heart failure during follow-up.	1 year
Lactate 24 hour clearance	1 year
Number of days of intensive care unit Number of days of intensive care unit	1 year

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul City, Seoul, Korea, Republic of