The Effects of IABP Prior to Revascularization on Mortality of ACS Patients Complicated With Cardiogenic Shock

U

University of Indonesia (UI)

Status

Completed

Conditions

Cardiogenic Shock

Treatments

Device: Intra Aortic Balloon Pump

Study type

Interventional

Funder types

Other

Identifiers

NCT03635840
IABP18

Details and patient eligibility

About

Prevalence of cardiogenic shock in acute coronary syndrome patients is reported at about 5-8% with high fatality. Revascularization approach has already known as the standard of care, but the usage of intra-aortic balloon pump (IABP) as mechanical circulatory support is still a controversy. IABP SHOCK II trial revealed that short-term mortality did not improved by IABP but there are several essential variabels related to mortality that are not considered in the study which are IABP initiation time and weaning protocol.This study aim to evalute the effect of IABP prior to revascularization on mortality of patients with myocardial infarction complicated with shock. 92 subjects will be enrolled in this randomized controlled trial into two groups, with and without IABP. IABP group will be receiving the intervention prior to revascularization. The primary outcomes to be sought are in-hospital and 30-day mortality after revascularization. IABP effects measured by various indicators such as Global Longitudinal Strain by echocardiography on the 1st and 3rd day, NTproBNP and ST2 level on the 1st, 3rd and 5th day, effective lactate clearance and ureum creatinine level on the 1st and 3rd day and will be compared between two groups. Continous variabel will be presented in mean ± deviation standard or median, and analized with Student's t test or Mann-Whitney U test as appropriate.

Enrollment

34 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age greater than 18 years old
  • Myocardial infarction patients complicated with shock
  • Willing to enroll in the study (signed consent)

Exclusion criteria

  • Age greater than 80 years old
  • Heart and lung resuscitation for more than 30 minutes
  • Cardiogenic shock onset >12 hours (if known) or >18 hours (if not known/patient presented in emergency department already with shock)
  • Mechanical complication of myocardial infarction
  • Moderate and severe aorta regurgitation
  • Peripheral artery disease making IABP unfeasible
  • Patients not receiving revascularization by percutaneous coronary intervention
  • Patients who died before IABP insertion
  • Care termination requested by family

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

34 participants in 2 patient groups

Control
No Intervention group
Description:
Group of patients not receiving IABP
Intra Aortic Balloon Pump
Experimental group
Description:
Group of patients receiving Intra Aortic Balloon Pump prior to revascularization
Treatment:
Device: Intra Aortic Balloon Pump

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Arum Suryandari, MD; Dafsah Juzar, MD

Data sourced from clinicaltrials.gov

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