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Optimal Flow Rate During Cardiopulmonary Bypass

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2014 by Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01105078
First Posted: April 16, 2010
Last Update Posted: August 6, 2014
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 (Responsible Party):
Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals
  Purpose

Regardless of the development of cardiac surgery techniques and technologies, the question of an optimal extracorporeal circulation is still unanswered. There are globally accepted standards of perfusion, however, keep many of these procedures was not evidence-based review.

Generally accepted are flow rates during cardiopulmonary bypasses of 2.5 L/min/m2. This target was derived from the physiological conditions, but they are not the result of an adapted adjustment to the fundamentally non-physiological processes during extracorporeal circulation. Among other things, an increased metabolic demand during re-perfusion is not taken into account.

An increasing and optimizing of the standard flow rate of 0.5 L/min/m2 should be the aim of this investigation. Under optimal perfusion, the investigators are maintaining the microcirculation and organ protection in receipt of endothelial function and oxygen transport.


Condition Intervention
Tissue Perfusion Procedure: Flow rate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimal Flow Rate During Cardiopulmonary Bypass

Further study details as provided by Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Microcirulation [ Time Frame: intraooperative ]
    measurement with O2C


Estimated Enrollment: 60
Study Start Date: May 2010
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Flow rate
Comparison between a flow rate of 2.5/l/min/m2 versus 3.0/l/min/m2
Procedure: Flow rate
Different flow rate during cardiopulmonary bypass

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Extracorporeal circulation
  • Age > 18
  • Written consent

Exclusion Criteria:

  • Emergency cases
  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): NCT01105078


Contacts
Contact: Arndt H Kiessling, MD +49696301 ext 6705 arndt.kiessling@kgu.de

Locations
Germany
Johann Wolfgang Goethe University Hospital Recruiting
Frankfurt am Main, Germany, 60590
Contact: Arndt H Kiessling, MD    +49696301 ext 6705    arndt.kiessling@kgu.de   
Principal Investigator: Andreas Zierer, MD         
Sub-Investigator: Arndt H Kiessling, MD         
Sub-Investigator: Eduard Manherz         
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
  More Information

Additional Information:
Responsible Party: Arndt-H. Kiessling, Head cardiovascular research, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01105078     History of Changes
Other Study ID Numbers: CI001AZ-AHK
First Submitted: April 15, 2010
First Posted: April 16, 2010
Last Update Posted: August 6, 2014
Last Verified: August 2014

Keywords provided by Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals:
cardiopulmonary bypass flow rate outcome tissue perfusion oxygenation l/min/m2