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Trial record 1 of 7 for:    IABP SHOCK II
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Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II)

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ClinicalTrials.gov Identifier: NCT00491036
Recruitment Status : Completed
First Posted : June 25, 2007
Last Update Posted : May 2, 2017
Information provided by (Responsible Party):
Holger Thiele, University of Leipzig

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Shock, Cardiogenic Device: Intraaortic balloon pump Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Study of Intraaortic Balloon Pump Use in Cardiogenic Shock Complicating Acute Myocardial Infarction
Study Start Date : June 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack Shock

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 30-day mortality [ Time Frame: 30 day ]

Secondary Outcome Measures :
  1. Inflammatory markers (CRP and white blood cell count) [ Time Frame: 4 days ]
  2. Hemodynamic Parameters (Blood pressure, Heart rate) [ Time Frame: 3 days ]
  3. Time till hemodynamic stabilization [ Time Frame: 30 days ]
  4. Catecholamine dose and duration of catecholamines [ Time Frame: 30 days ]
  5. Mean and area under the curve of serum lactate [ Time Frame: 48 hours ]
  6. Creatinine clearance until stabilization [ Time Frame: 4 days ]
  7. requirement for hemofiltration or dialysis [ Time Frame: 4 days ]
  8. length of ICU stay [ Time Frame: 30 days ]
  9. length of mechanical ventilation [ Time Frame: 30 days ]
  10. SAPS-II Score [ Time Frame: 4 days ]
  11. requirement for active assist device implantation or heart transplantation at 30 days and approximately 60 months [ Time Frame: 60 months ]
  12. long-term mortality at 6, 12 and approximately 60 months [ Time Frame: 60 months ]
  13. quality of life at 30 days and approximately 60 months [ Time Frame: 60 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00491036

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Sponsors and Collaborators
University of Leipzig
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Study Chair: Holger Thiele, MD Heart Center Leipzig - University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Holger Thiele, Deputy Director, University of Leipzig
ClinicalTrials.gov Identifier: NCT00491036    
Other Study ID Numbers: 342
First Posted: June 25, 2007    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017
Keywords provided by Holger Thiele, University of Leipzig:
Acute myocardial infarction
cardiogenic shock
percutaneous coronary intervention
intraaortic balloon counterpulsation
Acute myocardial infarction - cardiogenic shock
Additional relevant MeSH terms:
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Shock, Cardiogenic
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases