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

NCT03638609 | Unknown DMC

• 1 other identifier: IABP17
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Cardiac Arrest Syndrome

Keywords

IABP; Post-Cardiac Arrest Syndrome; Beclin-1; Caspase-3; Mortality

Outcome Measures

Primary Outcomes (1)

• In-Hospital Mortality

  Mortality of patients during the hospitalization receiving early insertion IABP

  30 days

Study Arms (2)

Control

NO INTERVENTION

Group of patients not receiving IABP

Intra Aortic Balloon Pump

EXPERIMENTAL

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

Device: Intra Aortic Balloon Pump

Interventions

Intra Aortic Balloon Pump DEVICE

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.

Also known as: IABP

Intra Aortic Balloon Pump

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead
• National Cardiovascular Center Harapan Kita Hospital Indonesia: collaborator

Study Sites (1)

National Cradiovascular Center Harapan Kita Hospital

Jakarta, 11420, Indonesia

RECRUITING

Related Publications (30)

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MeSH Terms

Conditions

Post-Cardiac Arrest Syndrome; Spinocerebellar Ataxias

Interventions

Intra-Aortic Balloon Pumping

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Heart Diseases; Cardiovascular Diseases; Reperfusion Injury; Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebellar Ataxia; Cerebellar Diseases; Spinocerebellar Degenerations; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Ataxia; Dyskinesias; Neurologic Manifestations; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Counterpulsation; Assisted Circulation; Surgical Procedures, Operative

Study Officials

• Isman Firdaus, MD

  National Cardiovascular Center Harapan Kita Hospital Indonesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isman Firdaus, MD

CONTACT

+621-5684093; ismanf@yahoo.com

Arum Suryandari, MD

CONTACT

+621-5684093; arumramadhyan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Cardiologist, Principal Investigator

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 20, 2018
• Study Start: October 23, 2017
• Primary Completion: October 23, 2018
• Study Completion: November 23, 2018
• Last Updated: August 20, 2018

Record last verified: 2018-08

Locations

ID (1)