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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00604331
First Posted: January 30, 2008
Last Update Posted: December 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Herzzentrum Goettingen
  Purpose
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.

Condition Intervention Phase
Shock, Cardiogenic Heart Failure Acute Myocardial Infarction Drug: Pyruvate Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Pyruvate in Patients With Cardiogenic Shock and Intra-aortic Balloon Counterpulsation

Resource links provided by NLM:


Further study details as provided by Herzzentrum Goettingen:

Primary Outcome Measures:
  • Cardiac Output [ Time Frame: 60 minutes ]

Secondary Outcome Measures:
  • Cardiac Index [ Time Frame: 60 minutes ]
  • Arterial Pressure [ Time Frame: 60 minutes ]
  • Pulmonary capillary wedge pressure [ Time Frame: 60 minutes ]
  • Pulmonary artery pressure [ Time Frame: 60 minutes ]
  • systemic vascular resistance [ Time Frame: 60 minutes ]
  • pulmonary vascular resistance [ Time Frame: 60 minutes ]
  • heart rate [ Time Frame: 60 minutes ]
  • stroke volume [ Time Frame: 60 minutes ]
  • catecholamine need [ Time Frame: 60 minutes ]
  • safety [ Time Frame: 60 minutes ]

Enrollment: 8
Study Start Date: August 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Pyruvate
Drug: Pyruvate
sodium pyruvate 300 mmol/L, 360 mL/h i.c. over 30 minutes.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00604331


Locations
Germany
Herzzentrum Goettingen, Cardiology and Pneumology
Goettingen, Germany, 37075
Sponsors and Collaborators
Herzzentrum Goettingen
Investigators
Principal Investigator: Gerd Hasenfuss, Prof. Dr. Herzzentrum Goettingen, Cardiology and Pneumology
  More Information

Additional Information:
Publications:
Responsible Party: Gerd Hasenfuss/Professor Dr. med., Cardiology and Pneumology
ClinicalTrials.gov Identifier: NCT00604331     History of Changes
Other Study ID Numbers: PYR-2008-01
12/10/00
First Submitted: January 17, 2008
First Posted: January 30, 2008
Last Update Posted: December 9, 2010
Last Verified: December 2010

Keywords provided by Herzzentrum Goettingen:
Pyruvic Acid
Shock, Cardiogenic
Catecholamines
Intra-Aortic Balloon Pumping
Cardiac Output
Cardiac Index
Cardiac Function

Additional relevant MeSH terms:
Heart Failure
Infarction
Myocardial Infarction
Shock
Shock, Cardiogenic
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases