The Effect of Intra Aortic Balloon Pump Early Insertion on Mortality in Post Cardiac Arrest Patients With Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- In-Hospital Mortality
研究概览
简要总结
The prevalence of cardiac arrests is still high worldwide. Despite the return of spontaneous circulation (ROSC), mortality and morbidity in post cardiac arrest patients is reported high. Comprehensive management is essential in treating patients with post cardiac arrest syndrome. Adequate circulatory stability is achieved with fluid therapy, vasoactive drug therapy, and consideration of mechanical support. Intra-Aortic Ballon Pump (IABP) is one of the most feasible and available mechanical support in developing countries including Indonesia.
There are several benefits of IABP reported in acute myocardial infarction complicated with cardiogenic shock. Nevertheless, the IABP-SHOCK II study revealed contradictive result which is IABP support was not improving mortality in acute myocardial infarction complicated with cardiogenic shock after revascularization. Other study, Korean Acute Myocardial Infarction Registry (KAMIR), also reported no benefits of IABP support in cardiogenic shock patients. But, the study the investigators mentioned earlier is a registry study, attributed to selection bias and several confounding factors resulting mismatch in population. There are no consideration to IABP time of initiation and duration of use in both studies.
The Investigator is aiming to prove the early insertion of IABP to a better outcome compared with the absence of early IABP. The objective of the study is to assess mortality in post cardiac arrest syndrome patients with early insertion of IABP support. A total of 102 subjects will be enrolled in this study, divided into IABP and non-IABP group. The primary outcome is in-hopital-mortality, and various indicators in the pathomechanisme of post cardiac arrest syndrome will be measured in 30 minutes and 6 hours after ROSC. Effective lactate clearance, IL-6, Beclin-1, Caspase-3, a-vO2 diff, and ScvO2, cardiac output, VTI, TAPSE and ejection fraction will be measured and analized between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 and less than 75 years.
- •Post cardiac arrest syndrome patients with decreased level of consciousness (cerebral performance categories (CPC) more than 1) and hypotension (systolic blood pressure less than 100)
- •Experiencing successful cardiac rescucitation following cardiac arrest
排除标准
- •History of stroke (based on interview)
- •Unequal pupil
- •Previous use of IABP
- •Aorta regurgitation
- •Brugada syndrome and congenital long QT
- •Drop-out Criteria:
- •Participants who died before IABP insertion
- •The family requests for a termination of treatment.
- •Anemia caused by bleeding with hemoglobin decrement by >3 gr/dL
- •Ankle brachial index(ABI) less than 0,8
研究组 & 干预措施
Control
Group of patients not receiving IABP
Intra Aortic Balloon Pump
Group of patients receiving Intra Aortic Balloon Pump in 3 hours after ROSC (early insertion of IABP)
干预措施: Intra Aortic Balloon Pump (Device)
结局指标
主要结局
In-Hospital Mortality
时间窗: 30 days
Mortality of patients during the hospitalization receiving early insertion IABP
次要结局
未报告次要终点
研究者
Isman Firdaus, MD
Interventional Cardiologist, Principal Investigator
Indonesia University