Clinical trial NCT00491036: Intraaortic Balloon Pump in Cardiogenic Shock II
Official title: Randomized Clinical Study of Intraaortic Balloon Pump Use in Cardiogenic Shock Complicating Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Shock, Cardiogenic
Keywords: Acute myocardial infarction
cardiogenic shock
percutaneous coronary intervention
intraaortic balloon counterpulsation
Acute myocardial infarction - cardiogenic shock
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2007-06-25
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 day
Secondary outcomes:
measure: Inflammatory markers (CRP and white blood cell count)
timeFrame: 4 days
measure: Hemodynamic Parameters (Blood pressure, Heart rate)
timeFrame: 3 days
measure: Time till hemodynamic stabilization
timeFrame: 30 days
measure: Catecholamine dose and duration of catecholamines
timeFrame: 30 days
measure: Mean and area under the curve of serum lactate
timeFrame: 48 hours
measure: Creatinine clearance until stabilization
timeFrame: 4 days
measure: requirement for hemofiltration or dialysis
timeFrame: 4 days
measure: length of ICU stay
timeFrame: 30 days
measure: length of mechanical ventilation
timeFrame: 30 days
measure: SAPS-II Score
timeFrame: 4 days
measure: requirement for active assist device implantation or heart transplantation at 30 days and approximately 60 months
timeFrame: 60 months
measure: long-term mortality at 6, 12 and approximately 60 months
timeFrame: 60 months
measure: quality of life at 30 days and approximately 60 months
timeFrame: 60 months
Other outcomes:
Locations:
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken Gmbh
city: Berlin
country: Germany
facility: Charité Berlin, Campus Benjamin Franklin
city: Bernau
country: Germany
facility: Heart Center Bernau - Brandenburg
city: Cottbus
country: Germany
facility: Herzzentrum Cottbus
city: Detmold
country: Germany
facility: Klinikum Lippe-Detmold
city: Fulda
country: Germany
facility: Krankenhaus Fulda
city: Greifswald
country: Germany
facility: University Greifswald
city: Halle
country: Germany
facility: Martin-Luther-Universität Halle-Wittenberg
city: Heilbronn
country: Germany
facility: SLK-Kliniken Heilbronn
city: Hennigsdorf
country: Germany
facility: Oberhavel-Kliniken Hennigsdorf
city: Jena
country: Germany
facility: Klinikum der Universität Jena
city: Langen
country: Germany
facility: Asklepios Klinik Langen
city: Leipzig
country: Germany
facility: University of Leipzig - Heart Center
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen am Rhein
city: Lübeck
country: Germany
facility: University of Lübeck
city: Magdeburg
country: Germany
facility: Otto-von-Guericke University Magdeburg
city: Munich
country: Germany
facility: German Heart Center Munich
city: Regensburg
country: Germany
facility: Krankenhaus der Barmherzigen Brüder
Study officials:
affiliation: Heart Center Leipzig - University Hospital
name: Holger Thiele, MD
role: STUDY_CHAIR
References:
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