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

Primary Purpose

Shock, Cardiogenic, Heart Failure, Acute Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Pyruvate
Sponsored by
Herzzentrum Goettingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shock, Cardiogenic focused on measuring Pyruvic Acid, Shock, Cardiogenic, Catecholamines, Intra-Aortic Balloon Pumping, Cardiac Output, Cardiac Index, Cardiac Function

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Herzzentrum Goettingen, Cardiology and Pneumology

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

A

Arm Description

Pyruvate

Outcomes

Primary Outcome Measures

Cardiac Output

Secondary Outcome Measures

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

Full Information

First Posted
January 17, 2008
Last Updated
December 7, 2010
Sponsor
Herzzentrum Goettingen
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1. Study Identification

Unique Protocol Identification Number
NCT00604331
Brief Title
Effects of Pyruvate in Patients With Cardiogenic Shock and Intra-aortic Balloon Counterpulsation
Official Title
Effects of Pyruvate in Patients With Cardiogenic Shock and Intra-aortic Balloon Counterpulsation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Herzzentrum Goettingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock, Cardiogenic, Heart Failure, Acute Myocardial Infarction
Keywords
Pyruvic Acid, Shock, Cardiogenic, Catecholamines, Intra-Aortic Balloon Pumping, Cardiac Output, Cardiac Index, Cardiac Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Pyruvate
Intervention Type
Drug
Intervention Name(s)
Pyruvate
Intervention Description
sodium pyruvate 300 mmol/L, 360 mL/h i.c. over 30 minutes.
Primary Outcome Measure Information:
Title
Cardiac Output
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Cardiac Index
Time Frame
60 minutes
Title
Arterial Pressure
Time Frame
60 minutes
Title
Pulmonary capillary wedge pressure
Time Frame
60 minutes
Title
Pulmonary artery pressure
Time Frame
60 minutes
Title
systemic vascular resistance
Time Frame
60 minutes
Title
pulmonary vascular resistance
Time Frame
60 minutes
Title
heart rate
Time Frame
60 minutes
Title
stroke volume
Time Frame
60 minutes
Title
catecholamine need
Time Frame
60 minutes
Title
safety
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerd Hasenfuss, Prof. Dr.
Organizational Affiliation
Herzzentrum Goettingen, Cardiology and Pneumology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herzzentrum Goettingen, Cardiology and Pneumology
City
Goettingen
ZIP/Postal Code
37075
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
10218531
Citation
Hermann HP, Pieske B, Schwarzmuller E, Keul J, Just H, Hasenfuss G. Haemodynamic effects of intracoronary pyruvate in patients with congestive heart failure: an open study. Lancet. 1999 Apr 17;353(9161):1321-3. doi: 10.1016/s0140-6736(98)06423-x.
Results Reference
background
PubMed Identifier
21132310
Citation
Schillinger W, Hunlich M, Sossalla S, Hermann HP, Hasenfuss G. Intracoronary pyruvate in cardiogenic shock as an adjunctive therapy to catecholamines and intra-aortic balloon pump shows beneficial effects on hemodynamics. Clin Res Cardiol. 2011 May;100(5):433-8. doi: 10.1007/s00392-010-0261-4. Epub 2010 Dec 4.
Results Reference
result

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

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