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Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by University of Leipzig.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00491036
First received: June 22, 2007
Last updated: August 2, 2011
Last verified: June 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Shock, Cardiogenic
 Device: Intraaortic balloon pump
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Clinical Study of Intraaortic Balloon Pump Use in Cardiogenic Shock Complicating Acute Myocardial Infarction

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack Shock
U.S. FDA Resources

Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • 30-day mortality [ Time Frame: 30 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammatory markers (CRP and white blood cell count) [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • Hemodynamic Parameters (Blood pressure, Heart rate) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Time till hemodynamic stabilization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Catecholamine dose and duration of catecholamines [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Mean and area under the curve of serum lactate [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Creatinine clearance until stabilization [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • requirement for hemofiltration or dialysis [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • length of ICU stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • length of mechanical ventilation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • SAPS-II Score [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • requirement for active assist device implantation or heart transplantation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • long-term mortality at 6 and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: June 2009
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intraaortic balloon pump
Patients in cardiogenic shock get an intraaortic balloon pump in the cath lab
 Device: Intraaortic balloon pump
intraaortic balloon pump from Datascope/Maquet or Arrow/Teleflex will be used
No Intervention: No intraaortic balloon pump
Patients in cardiogenic shock in this group get no intraaortic balloon pump

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00491036

Contacts
Contact: Holger Thiele, MD +49 341 8651426 thielh@medizin.uni-leipzig.de

Locations
Germany
Zentralklinik Bad Berka GmbH Recruiting
Bad Berka, Germany, 99437
Contact: Bernward Lauer, MD         b.lauer.kar@zentralklinik-bad-berka.de    
Principal Investigator: Bernward Lauer, MD            
Herzzentrum Bad Krozingen Recruiting
Bad Krozingen, Germany, 79189
Contact: Franz-Josef Neumann, MD         franz-josef.neumann@herzzentrum.de    
Principal Investigator: Franz-Josef Neumann, MD            
Segeberger Kliniken Gmbh Recruiting
Bad Segeberg, Germany, 23795
Contact: Gert Richardt, MD         gert.richardt@segebergerkliniken.de    
Principal Investigator: Gert Richardt, MD            
Charité Berlin, Campus Benjamin Franklin Recruiting
Berlin, Germany, 12200
Contact: Klaus Pels, MD         klaus.pels@charite.de    
Principal Investigator: Klaus Pels, MD            
Heart Center Bernau - Brandenburg Recruiting
Bernau, Germany, 16321
Contact: Christian Butter, MD         c.butter@immanuel.de    
Principal Investigator: Christian Butter, MD            
Herzzentrum Cottbus Recruiting
Cottbus, Germany, 03048
Contact: Jürgen Krülls-Münch, MD         kruells-muench@hz-cottbus.de    
Principal Investigator: Jürgen Krülls-Münch, MD            
Klinikum Lippe-Detmold Recruiting
Detmold, Germany, 32756
Contact: Ulrich Tebbe, MD         ulrich.tebbe@klinikum-lippe.de    
Principal Investigator: Ulrich Tebbe, MD            
Krankenhaus Fulda Recruiting
Fulda, Germany, 36043
Contact: Volker Schächinger, MD         schaechinger@em.uni-frankfurt.de    
Principal Investigator: Volker Schächinger, MD            
University Greifswald Recruiting
Greifswald, Germany, 17475
Contact: Klaus Empen, MD         empen@uni-greifswald.de    
Principal Investigator: Klaus Empen, MD            
Martin-Luther-Universität Halle-Wittenberg Recruiting
Halle, Germany, 06097
Contact: Karl Werdan, MD         karl.werdan@medizin.uni-halle.de    
Principal Investigator: Karl Werdan, MD            
SLK-Kliniken Heilbronn Recruiting
Heilbronn, Germany, 74078
Contact: Marcus Hennersdorf, MD         marcus.hennersdorf@slk-kliniken.de    
Principal Investigator: Marcus Hennersdorf, MD            
Oberhavel-Kliniken Hennigsdorf Recruiting
Hennigsdorf, Germany, 16761
Contact: Hans-Heinrich Minden, MD         minden@oberhavel-kliniken.de    
Principal Investigator: Hans-Heinrich Minden, MD            
Klinikum der Universität Jena Recruiting
Jena, Germany, 07747
Contact: Markus Ferrari, MD, PhD         Markus.Ferrari@med.uni-jena.de    
Principal Investigator: Markus Ferrari, MD, PhD            
Asklepios Klinik Langen Recruiting
Langen, Germany, 63225
Contact: Hans Hopf, MD         h-b.hopf@asklepios.com    
Contact: Hans Olbrich, MD         hg.olbrich@asklepios.com    
Principal Investigator: Hans Hopf, MD            
University of Leipzig - Heart Center Recruiting
Leipzig, Germany, 04289
Contact: Holger Thiele, MD     00493418651426     thielh@medizin.uni-leipzig.de    
Contact: Gerhard Schuler, MD     00493418651427     gerhard.schuler@med.uni-leipzig.de    
Principal Investigator: Holger Thiele, MD            
Klinikum der Stadt Ludwigshafen am Rhein Recruiting
Ludwigshafen, Germany, 67063
Contact: Uwe Zeymer, MD         zeymeru@klilu.de    
Principal Investigator: Uwe Zeymer, MD            
University of Lübeck Recruiting
Lübeck, Germany, 23538
Contact: Volkhard Kurowski, MD         Volkhard.Kurowski@uk-sh.de    
Principal Investigator: Volkhard Kurowski, MD            
Otto-von-Guericke University Magdeburg Recruiting
Magdeburg, Germany, 39120
Contact: Rüdiger C Braun-Dullaeus, MD         r.braun-dullaeus@med.ovgu.de    
Principal Investigator: Rüdiger C Braun-Dullaeus, MD            
German Heart Center Munich Recruiting
Munich, Germany, 80636
Contact: Melchior Seyfarth, MD         seyfarth@med1.med.tu-muenchen.de    
Principal Investigator: Melchior Seyfarth, MD            
Krankenhaus der Barmherzigen Brüder Recruiting
Regensburg, Germany, 93049
Contact: Peter Sick, MD         peter.sick@barmherzige-regensburg.de    
Principal Investigator: Peter Sick, MD            
Sponsors and Collaborators
University of Leipzig
Investigators
Study Chair: Holger Thiele, MD University of Leipzig
  More Information

No publications provided by University of Leipzig

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Holger Thiele, University of Leipzig - Heart Center
ClinicalTrials.gov Identifier: NCT00491036     History of Changes
Other Study ID Numbers: 342
Study First Received: June 22, 2007
Last Updated: August 2, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Leipzig:
Acute myocardial infarction
cardiogenic shock
percutaneous coronary intervention
intraaortic balloon counterpulsation
Acute myocardial infarction - cardiogenic shock

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Shock
Shock, Cardiogenic
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013