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

Primary Purpose

Post-Cardiac Arrest Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Intra Aortic Balloon Pump
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Cardiac Arrest Syndrome focused on measuring IABP, Post-Cardiac Arrest Syndrome, Beclin-1, Caspase-3, Mortality

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cradiovascular Center Harapan Kita HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intra Aortic Balloon Pump

Arm Description

Group of patients not receiving IABP

Group of patients receiving Intra Aortic Balloon Pump in 3 hours after ROSC (early insertion of IABP)

Outcomes

Primary Outcome Measures

In-Hospital Mortality
Mortality of patients during the hospitalization receiving early insertion IABP

Secondary Outcome Measures

Full Information

First Posted
August 9, 2018
Last Updated
August 15, 2018
Sponsor
Indonesia University
Collaborators
National Cardiovascular Center Harapan Kita Hospital Indonesia
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1. Study Identification

Unique Protocol Identification Number
NCT03638609
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 23, 2017 (Actual)
Primary Completion Date
October 23, 2018 (Anticipated)
Study Completion Date
November 23, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
Collaborators
National Cardiovascular Center Harapan Kita Hospital Indonesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Cardiac Arrest Syndrome
Keywords
IABP, Post-Cardiac Arrest Syndrome, Beclin-1, Caspase-3, Mortality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Group of patients not receiving IABP
Arm Title
Intra Aortic Balloon Pump
Arm Type
Experimental
Arm Description
Group of patients receiving Intra Aortic Balloon Pump in 3 hours after ROSC (early insertion of IABP)
Intervention Type
Device
Intervention Name(s)
Intra Aortic Balloon Pump
Other Intervention Name(s)
IABP
Intervention Description
Intra Aortic Balloon Pump (IABP) is a circulatory mechanical support device, placed in descending aorta, distally from left subclavian artery and proximally from renal artery. IABP works with counterpulsation concept, synchronized with heart cycle. It is indicated as supportive therapy for patients undergoing revascularization, cardiogenic shock and mechanical complication. Balloon dilatation during dyastolic phase increasing dyastolic pressure in aorta, improving coronary vascularization and myocardial oxygen supply. In systolic phase, the balloon deflates, reducing the left ventricle afterload hence decreasing myocardial oxygen demand.
Primary Outcome Measure Information:
Title
In-Hospital Mortality
Description
Mortality of patients during the hospitalization receiving early insertion IABP
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isman Firdaus, MD
Phone
+621-5684093
Ext
1265
Email
ismanf@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Arum Suryandari, MD
Phone
+621-5684093
Ext
1265
Email
arumramadhyan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isman Firdaus, MD
Organizational Affiliation
National Cardiovascular Center Harapan Kita Hospital Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cradiovascular Center Harapan Kita Hospital
City
Jakarta
ZIP/Postal Code
11420
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isman Firdaus, MD
Phone
+621-5684093
Ext
1265
Email
ismanf@yahoo.com
First Name & Middle Initial & Last Name & Degree
Gloria Kartika, MD
Phone
+621-5684093
Ext
1265
Email
gloria_kartika@yahoo.com
First Name & Middle Initial & Last Name & Degree
Isman Firdaus, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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The Effect of IABP Early Insertion on Mortality in Post Cardiac Arrest Patients With Acute Coronary Syndrome

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