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Optimal Flow Rate During Cardiopulmonary Bypass

This study is currently recruiting participants.
Verified June 2012 by Johann Wolfgang Goethe University Hospitals
Sponsor:
Information provided by (Responsible Party):
Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01105078
First received: April 15, 2010
Last updated: June 4, 2012
Last verified: June 2012
History of Changes
  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
Official Title: Optimal Flow Rate During Cardiopulmonary Bypass

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Study Start Date: May 2010
Estimated Primary Completion Date: December 2012 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Extracorporeal circulation
  • Age > 18
  • Written consent

Exclusion Criteria:

  • Emergency cases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 Hospitals
  More Information

Additional Information:
Klinikum der Johann Wolfgang Goethe Universität Frankfurt aM Germany  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: April 15, 2010
Last Updated: June 4, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:
cardiopulmonary bypass flow rate outcome tissue perfusion oxygenation l/min/m2

ClinicalTrials.gov processed this record on May 16, 2013