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OpenTrials
Completed

NCT Number: NCT00604331

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

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.

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Key information

Conditions

Shock, Cardiogenic Acute Myocardial Infarction Cardiovascular Diseases Heart Diseases Heart Failure Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Herzzentrum Goettingen, Cardiology and Pneumology

Göttingen, 37075, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pyruvate

Drug

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

Primary outcomes

  1. Cardiac Output

    Time frame: 60 minutes

Secondary outcomes

  1. Cardiac Index

    Time frame: 60 minutes

  2. Arterial Pressure

    Time frame: 60 minutes

  3. Pulmonary capillary wedge pressure

    Time frame: 60 minutes

  4. Pulmonary artery pressure

    Time frame: 60 minutes

  5. systemic vascular resistance

    Time frame: 60 minutes

  6. pulmonary vascular resistance

    Time frame: 60 minutes

  7. heart rate

    Time frame: 60 minutes

  8. stroke volume

    Time frame: 60 minutes

  9. catecholamine need

    Time frame: 60 minutes

  10. safety

    Time frame: 60 minutes

Sponsors and collaborators

Lead sponsor

Herzzentrum Goettingen

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 30, 2008
Registry last updated
Dec 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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