Effects of Pyruvate in Patients With Cardiogenic Shock and Intra-aortic Balloon Counterpulsation

Study Overview
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Brief Summary
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Pyruvate is an intermediate of energy metabolism and was shown to possess pronounced positive inotropic effects in vitro and in vivo without altering myocardial oxygen consumption. Moreover, it was shown that the effects of beta-adrenergic stimulation were potentiated. Thus, it might be possible to save catecholamines in patients with severe heart failure or cardiogenic shock. This study was designed to test the hemodynamic effects of pyruvate administered into a coronary artery in addition to intra-aortic balloon pump counterpulsation in patients with severe heart failure or in patients with acute myocardial infarction and cardiogenic shock after having performed percutaneous coronary intervention. A pronounced improvement in hemodynamics is expected to occur.

Official Title
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Effects of Pyruvate in Patients With Cardiogenic Shock and Intra-aortic Balloon Counterpulsation

Conditions
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Shock, Cardiogenic, Heart Failure, Acute Myocardial Infarction

Intervention / Treatment
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* Drug: Pyruvate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized patients male/female Age: 18 - 85 years Weight: 45 - 110 kg Height 150 - 195 cm Clinically signs of heart failure (NYHA III-IV) refractary to therapy or cardiogenic shock in acute myocardial infarction written informed consent or witnessed verbal consent or presumed will (compassionate use) Exclusion Criteria: Malignoma Clinically significant cardiac valve stenosis Participation in another clinical trial with relevant or probable drug-interactions Pregnancy or lactation Addiction Poor compliance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Pyruvate | Drug: Pyruvate<br>* sodium pyruvate 300 mmol/L, 360 mL/h i.c. over 30 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Output |  | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Index |  | 60 minutes | 
| Arterial Pressure |  | 60 minutes | 
| Pulmonary capillary wedge pressure |  | 60 minutes | 
| Pulmonary artery pressure |  | 60 minutes | 
| systemic vascular resistance |  | 60 minutes | 
| pulmonary vascular resistance |  | 60 minutes | 
| heart rate |  | 60 minutes | 
| stroke volume |  | 60 minutes | 
| catecholamine need |  | 60 minutes | 
| safety |  | 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pyruvic Acid, Shock, Cardiogenic, Catecholamines, Intra-Aortic Balloon Pumping, Cardiac Output, Cardiac Index, Cardiac Function