The Effect of Intra Aortic Balloon Pump Early Insertion on Mortality in Post Cardiac Arrest Patients With Acute Coronary Syndrome
Phase: NA
Conditions: Post-Cardiac Arrest Syndrome
Sponsor: Indonesia University

 
 
The Effect of Intra Aortic Balloon Pump Early Insertion 
on Mortality in Post Cardiac Arrest Patients with Acute 
Coronary Syndrome 
 
 
Date: 23th October 2017 
 
 
Isman Firdaus, MD, FIHA, FAPSIC, FAsCC, FESC, FSCAI 
 
 
 

 
 
Study Protocol 
Title 
Principal Investigator 
Isman Firdaus, MD 
National Cardiovascular Center Harapan Kita Hospital, Indonesia 
Sponsor 
Indonesia University 
Aim 
To observe the effects of intra aortic balloon pump on clinical outcomes of cardiac arrest 
patients and prognosis improvement through circulation and tissue perfusion 
improvement. 
Study Design 
Randomized clinical trial. 
Anticipated Outcome 
Early insertion of intra aortic balloon pump will be improving in-hospital mortality rate of 
cardiac arrest patients with acute coronary syndrome.  
Inclusion and Exclusion Criteria 
Inclusion Criteria 
1. Cardiac arrest survivor patients with acute coronary syndrome 
2. Age over 18 years and less than 75 years 
Exclusion Criteria 
1. History of stroke based on anamnesis 
2. Unequal pupil 
3. History of previous inta aortic balloon pump usage 
4. Aortic regurgitation 
5. Brugada and congenital long QT syndrome 
 
Withdrawal or Discontinuation Criteria 
1. Patient dies prior to intra aortic balloon pump insertion 
2. Treatment termination requasted by family 
3. Anemia due to hemorrhage with a decrease in Hb> 3 g / dL 
4. Ankle brachial index (ABI) less than 0.8 
Procedures 
1. Patients who meet the criteria and agree to participate in the study taken as the subject 
of the research. 
2. Research subjects were then randomized into two groups. The control group (Group 
A) and the treatment group (Group B) as the group that receiving intra aortic balloon 
pump (IABP)  as early as possible within 3 hours after the return of spontaneous 
circulation (ROSC). IABP insertion  is performed by an interventionist. 
3. Baseline data such as age, weight, height, risk factor (hypertension, Diabetes Mellitus, 
The Effect of Intra Aortic Balloon Pump Early Insertion on Mortality in Post Cardiac 
Arrest Patients with Acute Coronary Syndrome   

 
 
dyslipidemia, smoking, family history), history of Acute Myocardial Infarct (AMI), 
Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Graft (CABG), 
and valvular disease will be taken. Vital signs examination and EKG 12 leads will be 
performed.  
- Laboratory tests for peripheral venous blood include: Lactate levels, urea (Ur), 
creatinine (Cr), n-terminal pro B-type natriuretic peptide (NT Pro BNP), high 
sensitive troponin (Hs Trop), IL-6, beclin 1 and caspase 3.  
- Central venous blood examination for central venous blood gas analysis includes 
assessment of a-vO2 diff and ScvO2.  
- Arterial blood examination for arterial blood gas analysis. 
Monitoring of hemodynamic parameters using echocardiography machines 
(ejection fraction, TAPSE, cardiac output, VTI). 
4. In the group B, IABP is initiated within 3 hours after the return of spontaneous 
circulation by the interventionist.  
5. Blood sampling is repeated at 6th hour post ROSC or 1 hour post-insertion of IABP 
consisting of: 
- Laboratory tests for peripheral venous blood include lactate, IL-6, beclin-1 and 
caspase 3 levels. 
- Central venous blood examination for central venous blood gas analysis includes 
assessment of a-vO2 diff and ScvO2. 
- Arterial blood examination for arterial blood gas analysis. 
 Examination of hemodynamic parameters with echocardiographic machine was 
repeated at the 6th hour post ROSC, consisting of ejection fraction, TAPSE, cardiac 
output, VTI). 
6. Research subjects will be monitored during hospitalization.  
Analysis Method  
Data analysis using SPSS 20.0 software program with appropriate statistical test. Data 
taken during the study will be displayed according to the variable type. 
Numerical variables with normal distribution will be displayed as mean ± standard 
deviation, which is then analyzed by a general linear model (GLM) test for data measured 
more than once (IL-6, Beclin-1, Caspase-3, a- vO2 diff, and ScvO2) and independent t test 
for data with one time measurement (mortality rate in hospital and effective lactate 
clearance). Numerical variables with abnormal distribution will be shown in median 
(minimum-maximum) and then analyzed by Mann-Whitney test. The categorical variable 
will be displayed as a percentage (number) and will be analyzed by chi-square test or 
alternate test. 
Treatment Duration 
During hospitalization 
Primary Outcome 
In-hospital mortality 
 
 
 

 
 
SUBJECT INFORMATION AND CONSENT FORM 
The study aim to observe the effect of Intra Aortic Ballon Pump (IABP) early insertion on 
mortality of post cardiac arrest patient with acute coronary syndrome in National 
Cardiovascular Center Harapan Kita Hospital.   
102 individuals will be enrolled in the study. The duration of participation of each subject is 
during the hospitalisation. 
 
A. 
 Participation in the research 
You are free to participate in this study without any coercion. Once you have decided 
to participate, you are also free to resign / change your mind at any time without any 
penalty. If you refuse to participate then the patient will still be treated according to 
hospital procedures. 
 
B. 
Research Procedures 
1. 
Patient personal data and history will be taken: name, age, history of disease, smoking 
and family history. 
2. 
Physical examination will be performed to obtain vital signs and urine production. 
3. 
At 30 minutes after the return of spontaneous circulation, peripheral blood sampling 
will be done as much as 12 ml for laboratory examination of various clinical 
indicators. 
4. 
Echocardiography examination will also be done to determine the patient's 
hemodynamic status. 
5. 
If the patient is receiving IABP, the insertion will be done in 3 hours after the return 
of spontaeous circulation by an interventionalist. 
6. 
At 6 hours after the return of spontaneous circulation, peripheral blood sampling will 
be done for the second time. Echocardiography examination will also be performed. 
7. 
The patient's condition and progress will be monitored during hospitalization 
 
C. 
Risks and Side Effects 
Complications that may occur in the intra-aortic balloon pump insertion including 
blood vessel-related complications such as angio-ischemia, thrombocytopenia, 
infection, tearing of the aortic vessels, renal failure, neurological disorders, and 
bleeding. Studies show a complication of limb ischemia of less than 1%. Bleeding 
occurred in 0.8% of cases. If acute limb ischemia is occured, duplex evaluation and 
the removal of intra-aortic balloon pump will be done continued with fibrinolytic 
therapy or thrombus transcatheter aspiration. 
 
 
 
 
 

 
 
D. Benefits 
This study will prove the benefit of the intra-aortic balloon pump early insertion in 
improving the prognosis of cardiac arrest patients, therefore increase the life expectancy 
of cardiac arrest survivor. 
 
E. Confidentiality 
All information relating to the study will be kept confidential and will be known only to 
researchers and research staff. The results of the study will be published without the 
identity of the study subjects. 
 
F. Financing 
All research related costs will be borne by researchers and National Cardiovascular 
Center Harapan Kita Hospital. 
 
G. Additional Information 
If at any time further explanations are needed, you can contact Isman Firdaus, MD at 
ICVCU 
National 
Cardiovascular 
Center 
Harapan 
Kita 
Hospital. 
You can also inquire the information about the research from the Research Ethics 
Committee of National Cardiovascular Center Harapan Kita Hospital, Phone +62-
5681111, ext. 2837/2831 or email: irb.kometik_rsjpdhk@gmail.com. 

 
 
SUBJECT INFORMATION AND CONSENT FORM 
 
Name 
 
: 
Age 
 
: 
Gender 
 
: 
Address 
 
: 
ID number   
: 
 
As myself / husband / wife / child / parent / sibling * of: 
Name 
: 
Date of birth  : 
Gender 
 
: 
Address 
 
: 
 
 
With this stated AGREE to participate in the study. The purpose, nature, benefits of this 
study, and the risks it may cause has been adequately explained by the physician / researcher 
and 
I 
have 
fully 
understood. 
This consent I make with full consciousness and without coercion. 
 
Signature : _________________ 
 
Date  
: _________________ 
 
*cross the unnecessary ones