Intraaortic Balloon Pump in Cardiogenic Shock II

Study Overview
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Brief Summary
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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.

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

Conditions
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Myocardial Infarction, Shock, Cardiogenic

Intervention / Treatment
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* Device: Intraaortic balloon pump


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intraaortic balloon pump<br>Patients in cardiogenic shock get an intraaortic balloon pump in the cath lab | Device: Intraaortic balloon pump<br>* intraaortic balloon pump from Datascope/Maquet or Arrow/Teleflex will be used<br>|
| No Intervention: No intraaortic balloon pump<br>Patients in cardiogenic shock in this group get no intraaortic balloon pump | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality |  | 30 day | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiogenic shock, Acute myocardial infarction, percutaneous coronary intervention, intraaortic balloon counterpulsation, Acute myocardial infarction - cardiogenic shock