Clinical Trial: Intraaortic Balloon Pump in Cardiogenic Shock II

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Clinical Study of Intraaortic Balloon Pump Use in Cardiogenic Shock Complicating Acute Myocardial Infarction

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.


Detailed Summary:
Sponsor: University of Leipzig

Current Primary Outcome: 30-day mortality [ Time Frame: 30 day ]

Original Primary Outcome: mortality [ Time Frame: 30 day ]

Current Secondary Outcome:

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


Original Secondary Outcome: 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 ]

Information By: University of Leipzig

Dates:
Date Received: June 22, 2007
Date Started: June 2009
Date Completion:
Last Updated: May 1, 2017
Last Verified: May 2017