The Effect of IABP Early Insertion on Mortality in Post Cardiac Arrest Patients With Acute Coronary Syndrome
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|ClinicalTrials.gov Identifier: NCT03638609|
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : August 20, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Post-Cardiac Arrest Syndrome||Device: Intra Aortic Balloon Pump||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Intra Aortic Balloon Pump Early Insertion on Mortality in Post Cardiac Arrest Patients With Acute Coronary Syndrome|
|Actual Study Start Date :||October 23, 2017|
|Estimated Primary Completion Date :||October 23, 2018|
|Estimated Study Completion Date :||November 23, 2018|
No Intervention: Control
Group of patients not receiving IABP
Experimental: Intra Aortic Balloon Pump
Group of patients receiving Intra Aortic Balloon Pump in 3 hours after ROSC (early insertion of IABP)
Device: Intra Aortic Balloon Pump
Intra Aortic Balloon Pump (IABP) is a circulatory mechanical support device, placed in descending aorta, distally from left subclavian artery and proximally from renal artery. IABP works with counterpulsation concept, synchronized with heart cycle. It is indicated as supportive therapy for patients undergoing revascularization, cardiogenic shock and mechanical complication.
Balloon dilatation during dyastolic phase increasing dyastolic pressure in aorta, improving coronary vascularization and myocardial oxygen supply. In systolic phase, the balloon deflates, reducing the left ventricle afterload hence decreasing myocardial oxygen demand.
Other Name: IABP
- In-Hospital Mortality [ Time Frame: 30 days ]Mortality of patients during the hospitalization receiving early insertion IABP
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638609
|Contact: Isman Firdaus, MD||+621-5684093 ext email@example.com|
|Contact: Arum Suryandari, MD||+621-5684093 ext firstname.lastname@example.org|
|National Cradiovascular Center Harapan Kita Hospital||Recruiting|
|Jakarta, Indonesia, 11420|
|Contact: Isman Firdaus, MD +621-5684093 ext 1265 email@example.com|
|Contact: Gloria Kartika, MD +621-5684093 ext 1265 firstname.lastname@example.org|
|Principal Investigator: Isman Firdaus, MD|
|Principal Investigator:||Isman Firdaus, MD||National Cardiovascular Center Harapan Kita Hospital Indonesia|