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Clinical Trials/NCT03638609
NCT03638609
Unknown
N/A

The Effect of Intra Aortic Balloon Pump Early Insertion on Mortality in Post Cardiac Arrest Patients With Acute Coronary Syndrome

Indonesia University1 site in 1 country102 target enrollmentOctober 23, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Post-Cardiac Arrest Syndrome
Sponsor
Indonesia University
Enrollment
102
Locations
1
Primary Endpoint
In-Hospital Mortality
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 23, 2017
End Date
November 23, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Isman Firdaus, MD

Interventional Cardiologist, Principal Investigator

Indonesia University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

In-Hospital Mortality

Time Frame: 30 days

Mortality of patients during the hospitalization receiving early insertion IABP

Study Sites (1)

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