Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

June 22, 2007
June 17, 2013
June 2009
June 2012   (final data collection date for primary outcome measure)
30-day mortality [ Time Frame: 30 day ] [ Designated as safety issue: No ]
mortality [ Time Frame: 30 day ]
Complete list of historical versions of study NCT00491036 on ClinicalTrials.gov Archive Site
  • 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 ]
Key secondary endpoint(s): hemodynamic parameters, catecholamine dose, APACHE-II-score, inflammatory markers, serum lactate Assessment of safety: major bleeding complications, peripheral ischemic vascu-lar complications [ Time Frame: 30 days ]
Not Provided
Not Provided
 
Intraaortic Balloon Pump in Cardiogenic Shock II
Randomized Clinical Study of Intraaortic Balloon Pump Use in Cardiogenic Shock Complicating Acute Myocardial Infarction

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Myocardial Infarction
  • Shock, Cardiogenic
Device: Intraaortic balloon pump
intraaortic balloon pump from Datascope/Maquet or Arrow/Teleflex will be used
  • Active Comparator: Intraaortic balloon pump
    Patients in cardiogenic shock get an intraaortic balloon pump in the cath lab
    Intervention: Device: Intraaortic balloon pump
  • No Intervention: No intraaortic balloon pump
    Patients in cardiogenic shock in this group get no intraaortic balloon pump

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
June 2013
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00491036
342
Yes
Holger Thiele, University of Leipzig
University of Leipzig
Not Provided
Study Chair: Holger Thiele, MD University of Leipzig
University of Leipzig
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP