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
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
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
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
NCT ID
NCT03638609
First Posted
August 9, 2018
Last Updated
August 15, 2018
Sponsor
Indonesia University
Collaborators
National Cardiovascular Center Harapan Kita Hospital Indonesia
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
Citations:
PubMed Identifier
26690649
Citation
Adams JA, Uryash A, Nadkarni V, Berg RA, Lopez JR. Whole body periodic acceleration (pGz) preserves heart rate variability after cardiac arrest. Resuscitation. 2016 Feb;99:20-5. doi: 10.1016/j.resuscitation.2015.11.018. Epub 2015 Dec 12.
Results Reference
background
PubMed Identifier
18948368
Citation
Neumar RW, Nolan JP, Adrie C, Aibiki M, Berg RA, Bottiger 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. No abstract available.
Results Reference
background
PubMed Identifier
21464058
Citation
Stub D, Bernard S, Duffy SJ, Kaye DM. Post cardiac arrest syndrome: a review of therapeutic strategies. Circulation. 2011 Apr 5;123(13):1428-35. doi: 10.1161/CIRCULATIONAHA.110.988725. No abstract available.
Results Reference
background
Citation
Firdaus I. Registry of Acute and Intensive Cardiovascular Care on Outcome (RAICOM) in National Cardiovascular Center Harapan Kita Indonesia. 2016.
Results Reference
background
Citation
iSTEMI (Indonesia STEMI). 2016
Results Reference
background
PubMed Identifier
26421284
Citation
Jentzer JC, Chonde MD, Dezfulian C. Myocardial Dysfunction and Shock after Cardiac Arrest. Biomed Res Int. 2015;2015:314796. doi: 10.1155/2015/314796. Epub 2015 Sep 2.
Results Reference
background
PubMed Identifier
22053891
Citation
Mongardon N, Dumas F, Ricome S, Grimaldi D, Hissem T, Pene F, Cariou A. Postcardiac arrest syndrome: from immediate resuscitation to long-term outcome. Ann Intensive Care. 2011 Nov 3;1(1):45. doi: 10.1186/2110-5820-1-45.
Results Reference
background
PubMed Identifier
26670819
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.
Results Reference
background
PubMed Identifier
20097051
Citation
He C, Levine B. The Beclin 1 interactome. Curr Opin Cell Biol. 2010 Apr;22(2):140-9. doi: 10.1016/j.ceb.2010.01.001. Epub 2010 Jan 22.
Results Reference
background
PubMed Identifier
21311563
Citation
Kang R, Zeh HJ, Lotze MT, Tang D. The Beclin 1 network regulates autophagy and apoptosis. Cell Death Differ. 2011 Apr;18(4):571-80. doi: 10.1038/cdd.2010.191. Epub 2011 Feb 11.
Results Reference
background
PubMed Identifier
26626938
Citation
Green DR, Llambi F. Cell Death Signaling. Cold Spring Harb Perspect Biol. 2015 Dec 1;7(12):a006080. doi: 10.1101/cshperspect.a006080.
Results Reference
background
PubMed Identifier
23545416
Citation
McIlwain DR, Berger T, Mak TW. Caspase functions in cell death and disease. Cold Spring Harb Perspect Biol. 2013 Apr 1;5(4):a008656. doi: 10.1101/cshperspect.a008656. Erratum In: Cold Spring Harb Perspect Biol. 2015 Apr;7(4). pii: a026716. doi: 10.1101/cshperspect.a026716.
Results Reference
background
PubMed Identifier
23834359
Citation
Brentnall M, Rodriguez-Menocal L, De Guevara RL, Cepero E, Boise LH. Caspase-9, caspase-3 and caspase-7 have distinct roles during intrinsic apoptosis. BMC Cell Biol. 2013 Jul 9;14:32. doi: 10.1186/1471-2121-14-32.
Results Reference
background
PubMed Identifier
10200555
Citation
Porter AG, Janicke RU. Emerging roles of caspase-3 in apoptosis. Cell Death Differ. 1999 Feb;6(2):99-104. doi: 10.1038/sj.cdd.4400476.
Results Reference
background
PubMed Identifier
23415552
Citation
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.
Results Reference
background
PubMed Identifier
19752367
Citation
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.
Results Reference
background
PubMed Identifier
12957613
Citation
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. doi: 10.1016/s1053-2498(02)01160-9.
Results Reference
background
PubMed Identifier
24856512
Citation
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.
Results Reference
background
PubMed Identifier
26322188
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.
Results Reference
background
PubMed Identifier
24079682
Citation
Andersen LW, Mackenhauer J, Roberts JC, Berg KM, Cocchi MN, Donnino MW. Etiology and therapeutic approach to elevated lactate levels. Mayo Clin Proc. 2013 Oct;88(10):1127-40. doi: 10.1016/j.mayocp.2013.06.012.
Results Reference
background
PubMed Identifier
17077689
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. doi: 10.1097/MCC.0b013e328010ba4f.
Results Reference
background
PubMed Identifier
9434919
Citation
Mullner 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. doi: 10.1007/s001340050470.
Results Reference
background
PubMed Identifier
17583412
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. doi: 10.1016/j.resuscitation.2007.03.021. Epub 2007 Jun 20.
Results Reference
background
PubMed Identifier
24172276
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.
Results Reference
background
PubMed Identifier
21597442
Citation
Cocchi MN, Miller J, Hunziker S, Carney E, Salciccioli J, Farris S, Joyce N, Zimetbaum P, Howell MD, Donnino MW. The association of lactate and vasopressor need for mortality prediction in survivors of cardiac arrest. Minerva Anestesiol. 2011 Nov;77(11):1063-71. Epub 2011 May 11.
Results Reference
background
PubMed Identifier
21227564
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.
Results Reference
background
PubMed Identifier
25982668
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.
Results Reference
background
PubMed Identifier
22920912
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, Bohm 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.
Results Reference
background
PubMed Identifier
24011548
Citation
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, Bohm 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.
Results Reference
background
PubMed Identifier
24436615
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.
Results Reference
background
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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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