NCT03638609

The Effect of IABP Early Insertion on Mortality in Post Cardiac Arrest Patients With Acute Coronary Syndrome

Status unknown NA Last updated 20 August 2018

What this trial tests

NA trial testing Intra Aortic Balloon Pump in Post-Cardiac Arrest Syndrome in 102 participants. Status unknown.

Timeline

23 October 2017

Primary endpoint
23 October 2018

23 November 2018

Quick facts

Lead sponsor	Indonesia University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	102
Start date	23 October 2017
Primary completion	23 October 2018
Estimated completion	23 November 2018
Sites	1 location across Indonesia

Drugs / interventions tested

• Intra Aortic Balloon Pump

Conditions studied

• Post-Cardiac Arrest Syndrome — all drugs for Post-Cardiac Arrest Syndrome →

Sponsor

Indonesia University

Who can join

Adults 18 to 75, any sex, with Post-Cardiac Arrest Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.