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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 Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
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: August 5, 2014
Last verified: August 2014
  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
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 Hospital:

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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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 ClinicalTrials.gov identifier: NCT01105078

Locations
Germany
Johann Wolfgang Goethe University Hospital
Frankfurt am Main, Germany, 60590
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 
Study First Received: April 15, 2010
Last Updated: August 5, 2014
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on December 02, 2016