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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00604331

Enrollment

Registered

2008-01-30

Start date

2008-08-31

Completion date

2009-07-31

Last updated

2010-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction, Heart Failure, Shock, Cardiogenic

Keywords

Pyruvic Acid, Shock, Cardiogenic, Catecholamines, Intra-Aortic Balloon Pumping, Cardiac Output, Cardiac Index, Cardiac Function

Brief summary

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.

Interventions

DRUGPyruvate

sodium pyruvate 300 mmol/L, 360 mL/h i.c. over 30 minutes.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Cardiac Output	60 minutes

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026