Clinical Effects of Intra-aortic Balloon Support in Early Acute Coronary Syndrome and non-Acute Coronary Syndrome related Cardiogenic Shock: a Multicenter Randomized Controlled Trial - IABP ON-TIME

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 250 人开始时间: 待定最近更新: 2024年6月18日

适应症

试验速览

暂无简介。

•- Patient in cardiogenic shock, not fulfilling the definition for SCAI stage B
•or C. For definitions, please see chapter 4 of the IABP ON-TIME protocol
•(version 2.0).
•- Administration of >=2 inotropic or vasopressive agents at the time of
•randomization.
•- Administration of noradrenaline/norepinephrine exceeding 0.2 µg/kg/min at the
•time of randomization.
•- Suspected or known mechanical complication contributing to cardiogenic shock,
•e.g. ventricular septal defect or papillary muscle rupture.
•- Cardiogenic shock developing within 72 hours of a surgical procedure (i.e.
•low cardiac output with an inability to wean cardiopulmonary bypass).
•- Inability to provide informed consent. Of note: patients admitted in
•cardiogenic shock who required cardiopulmonary resuscitation earlier, but are
•conscious at the time of hospital admission, are eligible for study
•participation.
•- Known or suspected insufficiency of the aortic valve with at least moderate
•aortic regurgitation.
•- Known or suspected peripheral arterial disease preventing safe insertion of
•- Known or suspected thoracic or abdominal aortic disease (including aortic
•dissection or aortic aneurysm) precluding safe insertion and use of IABP.
•- Suspicion of sepsis or septic shock (including septic cardiomyopathy).
•- Pregnancy.
•- Predicted life expectancy <6 months because of concomitant disease.
•- Concurrent participation in a clinical trial with competing endpoints.

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