Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Optimal Flow Rate During Cardiopulmonary Bypass

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Johann Wolfgang Goethe University Hospitals
Information provided by (Responsible Party):
Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals Identifier:
First received: April 15, 2010
Last updated: August 5, 2014
Last verified: August 2014

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimal Flow Rate During Cardiopulmonary Bypass

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

Primary Outcome Measures:
  • Microcirulation [ Time Frame: intraooperative ] [ Designated as safety issue: Yes ]
    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


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

Inclusion Criteria:

  • Extracorporeal circulation
  • Age > 18
  • Written consent

Exclusion Criteria:

  • Emergency cases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01105078

Contact: Arndt H Kiessling, MD +49696301 ext 6705

Johann Wolfgang Goethe University Hospital Recruiting
Frankfurt am Main, Germany, 60590
Contact: Arndt H Kiessling, MD    +49696301 ext 6705   
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:
No publications provided

Responsible Party: Arndt-H. Kiessling, Head cardiovascular research, Johann Wolfgang Goethe University Hospitals Identifier: NCT01105078     History of Changes
Other Study ID Numbers: CI001AZ-AHK
Study First Received: April 15, 2010
Last Updated: August 5, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:
cardiopulmonary bypass flow rate outcome tissue perfusion oxygenation l/min/m2 processed this record on February 27, 2015