Clinical trial NCT02985008: Clinical Outcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With Cardiogenic Shock
Official title: SMart Angioplasty Research Team: A Multi-center, Open, REtrospective and Prospective Observational Study to Investigate Clinical oUtcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With Cardiogenic Shock : RESCUE
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shock, Cardiogenic
Keywords: Shock, IVBP, ECMO, In hospital death
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Total: 1,000

* Cardiogenic shock group with inserted IABP, ECMO : 400
* Cardiogenic shock group without inserted IABP, ECMO : 600

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.

Eligibility criteria: 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.

Primary outcomes:
measure: In hospital death
timeFrame: for 1 year
Secondary outcomes:
measure: Death in 28days
timeFrame: 28days
measure: Death in 1 year
timeFrame: 1 year
measure: Death, myocardial infarction, stroke, re-admission due to heart failure during follow-up.
timeFrame: 1 year
measure: Number of days of intensive care unit Number of days of intensive care unit
timeFrame: 1 year
measure: hospitalization days
timeFrame: 1 year
measure: Lactate 24 hour clearance
timeFrame: 1 year
measure: Successful removal of left ventricular assist device (IABP, ECMO)
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul City
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul
Study officials:
affiliation: Samsung Medical Center
name: Jeong Hoon Yang
role: STUDY_CHAIR
References:
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citation: Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, de Waha A, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Lauer B, Bohm M, Ebelt H, Schneider S, Werdan K, Schuler G; Intraaortic Balloon Pump in cardiogenic shock II (IABP-SHOCK II) trial investigators. Intra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock (IABP-SHOCK II): final 12 month results of a randomised, open-label trial. Lancet. 2013 Nov 16;382(9905):1638-45. doi: 10.1016/S0140-6736(13)61783-3. Epub 2013 Sep 3.
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