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

Post-Cardiac Arrest Syndrome Clinical Trial

Official title:

The Effect of Intra Aortic Balloon Pump Early Insertion on Mortality in Post Cardiac Arrest Patients With Acute Coronary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03638609
• Other study ID #: IABP17
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2017
• Est. completion date: November 23, 2018

Study information

• Verified date: August 2018
• Source: Indonesia University
• Contact: Isman Firdaus, MD
• Phone: +621-5684093
• Email: ismanf[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: November 23, 2018
• Est. primary completion date: October 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Heart Arrest
• Post-Cardiac Arrest Syndrome
• Syndrome

Intervention

Device:
• Intra Aortic Balloon Pump
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.

Locations

Country	Name	City	State
Indonesia	National Cradiovascular Center Harapan Kita Hospital	Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Indonesia University	National Cardiovascular Center Harapan Kita Hospital Indonesia

Country where clinical trial is conducted

Indonesia, 

References & Publications (30)

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de Jonge N, van Wichen DF, van Kuik J, Kirkels H, Lahpor JR, Gmelig-Meyling FH, van den Tweel JG, de Weger RA. Cardiomyocyte death in patients with end-stage heart failure before and after support with a left ventricular assist device: low incidence of apoptosis despite ubiquitous mediators. J Heart Lung Transplant. 2003 Sep;22(9):1028-36. — View Citation

Dharma S, Dakota I, Firdaus I, Wardeh AJ, Jukema JW. The Use of Intra-aortic Balloon Pump in a Real-World Setting: A Comparison between Survivors and Nonsurvivors from Acute Coronary Syndrome Treated with IABP. The Jakarta Acute Coronary Syndrome Registry. Int J Angiol. 2013 Dec;22(4):213-22. doi: 10.1055/s-0033-1348884. — View Citation

Donnino MW, Miller J, Goyal N, Loomba M, Sankey SS, Dolcourt B, Sherwin R, Otero R, Wira C. Effective lactate clearance is associated with improved outcome in post-cardiac arrest patients. Resuscitation. 2007 Nov;75(2):229-34. Epub 2007 Jun 20. — View Citation

Englehart MS, Schreiber MA. Measurement of acid-base resuscitation endpoints: lactate, base deficit, bicarbonate or what? Curr Opin Crit Care. 2006 Dec;12(6):569-74. Review. — View Citation

Firdaus I. Registry of Acute and Intensive Cardiovascular Care on Outcome (RAICOM) in National Cardiovascular Center Harapan Kita Indonesia. 2016.

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iSTEMI (Indonesia STEMI). 2016

Jahania SM, Sengstock D, Vaitkevicius P, Andres A, Ito BR, Gottlieb RA, Mentzer RM Jr. Activation of the homeostatic intracellular repair response during cardiac surgery. J Am Coll Surg. 2013 Apr;216(4):719-26; discussion 726-9. doi: 10.1016/j.jamcollsurg.2012.12.034. Epub 2013 Feb 13. — View Citation

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Kassiotis C, Ballal K, Wellnitz K, Vela D, Gong M, Salazar R, Frazier OH, Taegtmeyer H. Markers of autophagy are downregulated in failing human heart after mechanical unloading. Circulation. 2009 Sep 15;120(11 Suppl):S191-7. doi: 10.1161/CIRCULATIONAHA.108.842252. — View Citation

Kim HK, Jeong MH, Ahn Y, Sim DS, Chae SC, Kim YJ, Hur SH, Seong IW, Hong TJ, Choi DH, Cho MC, Kim CJ, Seung KB, Jang YS, Rha SW, Bae JH, Cho JG, Park SJ; other Korea Acute Myocardial Infarction Registry Investigators. Clinical outcomes of the intra-aortic balloon pump for resuscitated patients with acute myocardial infarction complicated by cardiac arrest. J Cardiol. 2016 Jan;67(1):57-63. doi: 10.1016/j.jjcc.2015.04.007. Epub 2015 May 14. — View Citation

Lazzeri C, Valente S, Chiostri M, Gensini GF. Clinical significance of lactate in acute cardiac patients. World J Cardiol. 2015 Aug 26;7(8):483-9. doi: 10.4330/wjc.v7.i8.483. Review. — View Citation

Lee TR, Kang MJ, Cha WC, Shin TG, Sim MS, Jo IJ, Song KJ, Jeong YK, Cho JH. Better lactate clearance associated with good neurologic outcome in survivors who treated with therapeutic hypothermia after out-of-hospital cardiac arrest. Crit Care. 2013 Oct 31;17(5):R260. doi: 10.1186/cc13090. — View Citation

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Müllner M, Sterz F, Domanovits H, Behringer W, Binder M, Laggner AN. The association between blood lactate concentration on admission, duration of cardiac arrest, and functional neurological recovery in patients resuscitated from ventricular fibrillation. Intensive Care Med. 1997 Nov;23(11):1138-43. — View Citation

Neumar RW, Nolan JP, Adrie C, Aibiki M, Berg RA, Böttiger BW, Callaway C, Clark RS, Geocadin RG, Jauch EC, Kern KB, Laurent I, Longstreth WT Jr, Merchant RM, Morley P, Morrison LJ, Nadkarni V, Peberdy MA, Rivers EP, Rodriguez-Nunez A, Sellke FW, Spaulding C, Sunde K, Vanden Hoek T. Post-cardiac arrest syndrome: epidemiology, pathophysiology, treatment, and prognostication. A consensus statement from the International Liaison Committee on Resuscitation (American Heart Association, Australian and New Zealand Council on Resuscitation, European Resuscitation Council, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Asia, and the Resuscitation Council of Southern Africa); the American Heart Association Emergency Cardiovascular Care Committee; the Council on Cardiovascular Surgery and Anesthesia; the Council on Cardiopulmonary, Perioperative, and Critical Care; the Council on Clinical Cardiology; and the Stroke Council. Circulation. 2008 Dec 2;118(23):2452-83. doi: 10.1161/CIRCULATIONAHA.108.190652. Epub 2008 Oct 23. — View Citation

Pellis T, Sanfilippo F, Ristagno G. The optimal hemodynamics management of post-cardiac arrest shock. Best Pract Res Clin Anaesthesiol. 2015 Dec;29(4):485-95. doi: 10.1016/j.bpa.2015.10.002. Epub 2015 Oct 14. Review. — View Citation

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Prescimone T, Masotti S, D'Amico A, Caruso R, Cabiati M, Caselli C, Viglione F, Verde A, Del Ry S, Giannessi D. Cardiac molecular markers of programmed cell death are activated in end-stage heart failure patients supported by left ventricular assist device. Cardiovasc Pathol. 2014 Sep-Oct;23(5):272-82. doi: 10.1016/j.carpath.2014.04.003. Epub 2014 Apr 13. — View Citation

Shinozaki K, Oda S, Sadahiro T, Nakamura M, Hirayama Y, Watanabe E, Tateishi Y, Nakanishi K, Kitamura N, Sato Y, Hirasawa H. Blood ammonia and lactate levels on hospital arrival as a predictive biomarker in patients with out-of-hospital cardiac arrest. Resuscitation. 2011 Apr;82(4):404-9. doi: 10.1016/j.resuscitation.2010.10.026. Epub 2011 Jan 11. — View Citation

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Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, de Waha A, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Lauer B, Böhm M, Ebelt H, Schneider S, Werdan K, Schuler G; Intraaortic Balloon Pump in cardiogenic shock II (IABP-SHOCK II) trial investigators. Intra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock (IABP-SHOCK II): final 12 month results of a randomised, open-label trial. Lancet. 2013 Nov 16;382(9905):1638-45. doi: 10.1016/S0140-6736(13)61783-3. Epub 2013 Sep 3. — View Citation

Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Fuhrmann J, Böhm M, Ebelt H, Schneider S, Schuler G, Werdan K; IABP-SHOCK II Trial Investigators. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med. 2012 Oct 4;367(14):1287-96. doi: 10.1056/NEJMoa1208410. Epub 2012 Aug 26. — View Citation

* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-Hospital Mortality	Mortality of patients during the hospitalization receiving early insertion IABP	30 days