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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Holger Thiele, University of Leipzig
ClinicalTrials.gov Identifier:
NCT00491036
First received: June 22, 2007
Last updated: June 17, 2013
Last verified: June 2013
  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:


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 ]

Enrollment: 600
Study Start Date: June 2009
Study Completion Date: June 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491036

Locations
Germany
Zentralklinik Bad Berka GmbH
Bad Berka, Germany, 99437
Herzzentrum Bad Krozingen
Bad Krozingen, Germany, 79189
Segeberger Kliniken Gmbh
Bad Segeberg, Germany, 23795
Charité Berlin, Campus Benjamin Franklin
Berlin, Germany, 12200
Heart Center Bernau - Brandenburg
Bernau, Germany, 16321
Herzzentrum Cottbus
Cottbus, Germany, 03048
Klinikum Lippe-Detmold
Detmold, Germany, 32756
Krankenhaus Fulda
Fulda, Germany, 36043
University Greifswald
Greifswald, Germany, 17475
Martin-Luther-Universität Halle-Wittenberg
Halle, Germany, 06097
SLK-Kliniken Heilbronn
Heilbronn, Germany, 74078
Oberhavel-Kliniken Hennigsdorf
Hennigsdorf, Germany, 16761
Klinikum der Universität Jena
Jena, Germany, 07747
Asklepios Klinik Langen
Langen, Germany, 63225
University of Leipzig - Heart Center
Leipzig, Germany, 04289
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen, Germany, 67063
University of Lübeck
Lübeck, Germany, 23538
Otto-von-Guericke University Magdeburg
Magdeburg, Germany, 39120
German Heart Center Munich
Munich, Germany, 80636
Krankenhaus der Barmherzigen Brüder
Regensburg, Germany, 93049
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, Deputy Director, University of Leipzig
ClinicalTrials.gov Identifier: NCT00491036     History of Changes
Other Study ID Numbers: 342
Study First Received: June 22, 2007
Last Updated: June 17, 2013
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 August 21, 2014