Back to resultsIntraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II)
Primary Purpose
Myocardial Infarction, Shock, Cardiogenic
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Intraaortic balloon pump
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring Acute myocardial infarction, cardiogenic shock, percutaneous coronary intervention, intraaortic balloon counterpulsation, Acute myocardial infarction - cardiogenic shock
Eligibility Criteria
Inclusion Criteria:
Cardiogenic shock complicating acute myocardial (STEMI or NSTEMI) with
- intended revascularization (PCI or CABG)
- Systolic blood pressure < 90 mmHg > 30 min or inotropes required to maintain pressure > 90 mmHg during systole
- Signs of pulmonary congestion
Signs of impaired organ perfusion with at least one of the following:
- Altered mental status
- Cold, clammy skin
- Urine output <30 ml/h
- Serum lactate >2mmol/l
- Informed consent
Exclusion criteria:
- Resuscitation > 30 minutes
- Cerebral deficit with fixed dilated pupils
- No intrinsic heart action
- Mechanical infarction complication
- Onset of shock > 12 h
- Severe peripheral artery disease
- Aortic regurgitation > II.°
- Age > 90 years
- shock of other cause
- Other severe concomitant disease
- participation in another trial
Sites / Locations
- Zentralklinik Bad Berka GmbH
- Herzzentrum Bad Krozingen
- Segeberger Kliniken Gmbh
- Charité Berlin, Campus Benjamin Franklin
- Heart Center Bernau - Brandenburg
- Herzzentrum Cottbus
- Klinikum Lippe-Detmold
- Krankenhaus Fulda
- University Greifswald
- Martin-Luther-Universität Halle-Wittenberg
- SLK-Kliniken Heilbronn
- Oberhavel-Kliniken Hennigsdorf
- Klinikum der Universität Jena
- Asklepios Klinik Langen
- University of Leipzig - Heart Center
- Klinikum der Stadt Ludwigshafen am Rhein
- University of Lübeck
- Otto-von-Guericke University Magdeburg
- German Heart Center Munich
- Krankenhaus der Barmherzigen Brüder
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intraaortic balloon pump
No intraaortic balloon pump
Arm Description
Patients in cardiogenic shock get an intraaortic balloon pump in the cath lab
Patients in cardiogenic shock in this group get no intraaortic balloon pump
Outcomes
Primary Outcome Measures
30-day mortality
Secondary Outcome Measures
Inflammatory markers (CRP and white blood cell count)
Hemodynamic Parameters (Blood pressure, Heart rate)
Time till hemodynamic stabilization
Catecholamine dose and duration of catecholamines
Mean and area under the curve of serum lactate
Creatinine clearance until stabilization
requirement for hemofiltration or dialysis
length of ICU stay
length of mechanical ventilation
SAPS-II Score
requirement for active assist device implantation or heart transplantation at 30 days and approximately 60 months
long-term mortality at 6, 12 and approximately 60 months
quality of life at 30 days and approximately 60 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00491036
Brief Title
Intraaortic Balloon Pump in Cardiogenic Shock II
Acronym
IABP-SHOCK II
Official Title
Randomized Clinical Study of Intraaortic Balloon Pump Use in Cardiogenic Shock Complicating Acute Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients in cardiogenic shock complicating acute myocardial infarction (AMI) are referred to a tertiary care center for percutaneous coronary intervention (PCI) of the infarct related artery in this multicenter, ran-domized clinical trial. After checking in- and exclusion criteria computerized randomization is performed to either PCI plus intraaortic balloon pump (IABP) insertion and medical treatment or PCI plus medical treatment only. Intensive care treatment is performed according to standard care including hemodynamic monitoring using a pulmonary artery catheter for optimal volume status adaptation and inotropic drug administration.
The IABP will be weaned after hemodynamic stabilization. Primary outcome measure will be 30-day mortality. The secondary outcome measures such as hemody-namic, laboratory and clinical parameters will serve as surrogate for prognosis of the patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Shock, Cardiogenic
Keywords
Acute myocardial infarction, cardiogenic shock, percutaneous coronary intervention, intraaortic balloon counterpulsation, Acute myocardial infarction - cardiogenic shock
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intraaortic balloon pump
Arm Type
Active Comparator
Arm Description
Patients in cardiogenic shock get an intraaortic balloon pump in the cath lab
Arm Title
No intraaortic balloon pump
Arm Type
No Intervention
Arm Description
Patients in cardiogenic shock in this group get no intraaortic balloon pump
Intervention Type
Device
Intervention Name(s)
Intraaortic balloon pump
Intervention Description
intraaortic balloon pump from Datascope/Maquet or Arrow/Teleflex will be used
Primary Outcome Measure Information:
Title
30-day mortality
Time Frame
30 day
Secondary Outcome Measure Information:
Title
Inflammatory markers (CRP and white blood cell count)
Time Frame
4 days
Title
Hemodynamic Parameters (Blood pressure, Heart rate)
Time Frame
3 days
Title
Time till hemodynamic stabilization
Time Frame
30 days
Title
Catecholamine dose and duration of catecholamines
Time Frame
30 days
Title
Mean and area under the curve of serum lactate
Time Frame
48 hours
Title
Creatinine clearance until stabilization
Time Frame
4 days
Title
requirement for hemofiltration or dialysis
Time Frame
4 days
Title
length of ICU stay
Time Frame
30 days
Title
length of mechanical ventilation
Time Frame
30 days
Title
SAPS-II Score
Time Frame
4 days
Title
requirement for active assist device implantation or heart transplantation at 30 days and approximately 60 months
Time Frame
60 months
Title
long-term mortality at 6, 12 and approximately 60 months
Time Frame
60 months
Title
quality of life at 30 days and approximately 60 months
Time Frame
60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cardiogenic shock complicating acute myocardial (STEMI or NSTEMI) with
intended revascularization (PCI or CABG)
Systolic blood pressure < 90 mmHg > 30 min or inotropes required to maintain pressure > 90 mmHg during systole
Signs of pulmonary congestion
Signs of impaired organ perfusion with at least one of the following:
Altered mental status
Cold, clammy skin
Urine output <30 ml/h
Serum lactate >2mmol/l
Informed consent
Exclusion criteria:
Resuscitation > 30 minutes
Cerebral deficit with fixed dilated pupils
No intrinsic heart action
Mechanical infarction complication
Onset of shock > 12 h
Severe peripheral artery disease
Aortic regurgitation > II.°
Age > 90 years
shock of other cause
Other severe concomitant disease
participation in another trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holger Thiele, MD
Organizational Affiliation
Heart Center Leipzig - University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Zentralklinik Bad Berka GmbH
City
Bad Berka
ZIP/Postal Code
99437
Country
Germany
Facility Name
Herzzentrum Bad Krozingen
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Segeberger Kliniken Gmbh
City
Bad Segeberg
ZIP/Postal Code
23795
Country
Germany
Facility Name
Charité Berlin, Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Heart Center Bernau - Brandenburg
City
Bernau
ZIP/Postal Code
16321
Country
Germany
Facility Name
Herzzentrum Cottbus
City
Cottbus
ZIP/Postal Code
03048
Country
Germany
Facility Name
Klinikum Lippe-Detmold
City
Detmold
ZIP/Postal Code
32756
Country
Germany
Facility Name
Krankenhaus Fulda
City
Fulda
ZIP/Postal Code
36043
Country
Germany
Facility Name
University Greifswald
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Martin-Luther-Universität Halle-Wittenberg
City
Halle
ZIP/Postal Code
06097
Country
Germany
Facility Name
SLK-Kliniken Heilbronn
City
Heilbronn
ZIP/Postal Code
74078
Country
Germany
Facility Name
Oberhavel-Kliniken Hennigsdorf
City
Hennigsdorf
ZIP/Postal Code
16761
Country
Germany
Facility Name
Klinikum der Universität Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Asklepios Klinik Langen
City
Langen
ZIP/Postal Code
63225
Country
Germany
Facility Name
University of Leipzig - Heart Center
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen am Rhein
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
University of Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Otto-von-Guericke University Magdeburg
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
German Heart Center Munich
City
Munich
ZIP/Postal Code
80636
Country
Germany
Facility Name
Krankenhaus der Barmherzigen Brüder
City
Regensburg
ZIP/Postal Code
93049
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
33647946
Citation
Ceglarek U, Schellong P, Rosolowski M, Scholz M, Willenberg A, Kratzsch J, Zeymer U, Fuernau G, de Waha-Thiele S, Buttner P, Jobs A, Freund A, Desch S, Feistritzer HJ, Isermann B, Thiery J, Poss J, Thiele H. The novel cystatin C, lactate, interleukin-6, and N-terminal pro-B-type natriuretic peptide (CLIP)-based mortality risk score in cardiogenic shock after acute myocardial infarction. Eur Heart J. 2021 Jun 21;42(24):2344-2352. doi: 10.1093/eurheartj/ehab110.
Results Reference
derived
PubMed Identifier
33032708
Citation
Fuernau G, Desch S, de Waha-Thiele S, Eitel I, Neumann FJ, Hennersdorf M, Felix SB, Fach A, Bohm M, Poss J, Jung C, Ouarrak T, Schneider S, Werdan K, Zeymer U, Thiele H. Arterial Lactate in Cardiogenic Shock: Prognostic Value of Clearance Versus Single Values. JACC Cardiovasc Interv. 2020 Oct 12;13(19):2208-2216. doi: 10.1016/j.jcin.2020.06.037.
Results Reference
derived
PubMed Identifier
30586721
Citation
Thiele H, Zeymer U, Thelemann N, Neumann FJ, Hausleiter J, Abdel-Wahab M, Meyer-Saraei R, Fuernau G, Eitel I, Hambrecht R, Bohm M, Werdan K, Felix SB, Hennersdorf M, Schneider S, Ouarrak T, Desch S, de Waha-Thiele S; IABP-SHOCK II Trial (Intraaortic Balloon Pump in Cardiogenic Shock II) Investigators; IABP-SHOCK II Investigators. Intraaortic Balloon Pump in Cardiogenic Shock Complicating Acute Myocardial Infarction: Long-Term 6-Year Outcome of the Randomized IABP-SHOCK II Trial. Circulation. 2019 Jan 15;139(3):395-403. doi: 10.1161/CIRCULATIONAHA.118.038201. Epub 2018 Nov 11.
Results Reference
derived
PubMed Identifier
28408020
Citation
Poss J, Koster J, Fuernau G, Eitel I, de Waha S, Ouarrak T, Lassus J, Harjola VP, Zeymer U, Thiele H, Desch S. Risk Stratification for Patients in Cardiogenic Shock After Acute Myocardial Infarction. J Am Coll Cardiol. 2017 Apr 18;69(15):1913-1920. doi: 10.1016/j.jacc.2017.02.027.
Results Reference
derived
PubMed Identifier
28174212
Citation
Ledwoch J, Fuernau G, Desch S, Eitel I, Jung C, de Waha S, Poess J, Schneider S, Schuler G, Werdan K, Zeymer U, Thiele H. Drug-eluting stents versus bare-metal stents in acute myocardial infarction with cardiogenic shock. Heart. 2017 Aug;103(15):1177-1184. doi: 10.1136/heartjnl-2016-310403. Epub 2017 Feb 7.
Results Reference
derived
PubMed Identifier
27928583
Citation
Jung C, Fuernau G, Eitel I, Desch S, Schuler G, Kelm M, Adams V, Thiele H. Incidence, laboratory detection and prognostic relevance of hypoxic hepatitis in cardiogenic shock. Clin Res Cardiol. 2017 May;106(5):341-349. doi: 10.1007/s00392-016-1060-3. Epub 2016 Dec 8.
Results Reference
derived
PubMed Identifier
27655918
Citation
Zeymer U, Werdan K, Schuler G, Zahn R, Neumann FJ, Furnau G, de Waha S, Schneider S, Thiele H. Editor's Choice- Impact of immediate multivessel percutaneous coronary intervention versus culprit lesion intervention on 1-year outcome in patients with acute myocardial infarction complicated by cardiogenic shock: Results of the randomised IABP-SHOCK II trial. Eur Heart J Acute Cardiovasc Care. 2017 Oct;6(7):601-609. doi: 10.1177/2048872616668977. Epub 2016 Sep 21.
Results Reference
derived
PubMed Identifier
26333723
Citation
Poss J, Fuernau G, Denks D, Desch S, Eitel I, de Waha S, Link A, Schuler G, Adams V, Bohm M, Thiele H. Angiopoietin-2 in acute myocardial infarction complicated by cardiogenic shock--a biomarker substudy of the IABP-SHOCK II-Trial. Eur J Heart Fail. 2015 Nov;17(11):1152-60. doi: 10.1002/ejhf.342. Epub 2015 Sep 3.
Results Reference
derived
PubMed Identifier
25720332
Citation
Jung C, Fuernau G, de Waha S, Eitel I, Desch S, Schuler G, Figulla HR, Thiele H. Intraaortic balloon counterpulsation and microcirculation in cardiogenic shock complicating myocardial infarction: an IABP-SHOCK II substudy. Clin Res Cardiol. 2015 Aug;104(8):679-87. doi: 10.1007/s00392-015-0833-4. Epub 2015 Feb 27.
Results Reference
derived
PubMed Identifier
25692257
Citation
Jung C, Fuernau G, Muench P, Desch S, Eitel I, Schuler G, Adams V, Figulla HR, Thiele H. Impairment of the endothelial glycocalyx in cardiogenic shock and its prognostic relevance. Shock. 2015 May;43(5):450-5. doi: 10.1097/SHK.0000000000000329. Erratum In: Shock. 2016 Apr;45(4):469. Shock. 2016 Jan 29;:
Results Reference
derived
PubMed Identifier
25637294
Citation
Schuster A, Faulkner M, Zeymer U, Ouarrak T, Eitel I, Desch S, Hasenfuss G, Thiele H. Economic implications of intra-aortic balloon support for myocardial infarction with cardiogenic shock: an analysis from the IABP-SHOCK II-trial. Clin Res Cardiol. 2015 Jul;104(7):566-73. doi: 10.1007/s00392-015-0819-2. Epub 2015 Jan 31.
Results Reference
derived
PubMed Identifier
25528363
Citation
Fuernau G, Poss J, Denks D, Desch S, Heine GH, Eitel I, Seiler S, de Waha S, Ewen S, Link A, Schuler G, Adams V, Bohm M, Thiele H. Fibroblast growth factor 23 in acute myocardial infarction complicated by cardiogenic shock: a biomarker substudy of the Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial. Crit Care. 2014 Dec 21;18(6):713. doi: 10.1186/s13054-014-0713-8.
Results Reference
derived
PubMed Identifier
24903195
Citation
Fuernau G, Poenisch C, Eitel I, de Waha S, Desch S, Schuler G, Adams V, Werdan K, Zeymer U, Thiele H. Growth-differentiation factor 15 and osteoprotegerin in acute myocardial infarction complicated by cardiogenic shock: a biomarker substudy of the IABP-SHOCK II-trial. Eur J Heart Fail. 2014 Aug;16(8):880-7. doi: 10.1002/ejhf.117. Epub 2014 Jun 5.
Results Reference
derived
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
derived
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
derived
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Intraaortic Balloon Pump in Cardiogenic Shock II
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