Clinical trial NCT03638609: The Effect of IABP Early Insertion on Mortality in Post Cardiac Arrest Patients With Acute Coronary Syndrome
Official title: The Effect of Intra Aortic Balloon Pump Early Insertion on Mortality in Post Cardiac Arrest Patients With Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-Cardiac Arrest Syndrome
Keywords: IABP
Post-Cardiac Arrest Syndrome
Beclin-1
Caspase-3
Mortality
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: National Cardiovascular Center Harapan Kita Hospital Indonesia
First posted: 2018-08-20
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age greater than 18 and less than 75 years.
2. 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)
3. Experiencing successful cardiac rescucitation following cardiac arrest

Exclusion Criteria:

1. History of stroke (based on interview)
2. Unequal pupil
3. Previous use of IABP
4. Aorta regurgitation
5. Brugada syndrome and congenital long QT

Drop-out Criteria:

1. Participants who died before IABP insertion
2. The family requests for a termination of treatment.
3. Anemia caused by bleeding with hemoglobin decrement by \>3 gr/dL
4. Ankle brachial index(ABI) less than 0,8

Primary outcomes:
measure: In-Hospital Mortality
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: National Cradiovascular Center Harapan Kita Hospital
Study officials:
affiliation: National Cardiovascular Center Harapan Kita Hospital Indonesia
name: Isman Firdaus, MD
role: PRINCIPAL_INVESTIGATOR
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