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Optimal Flow Rate During Cardiopulmonary Bypass

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ClinicalTrials.gov Identifier: NCT01105078
Recruitment Status : Unknown
Verified August 2014 by Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
First Posted : April 16, 2010
Last Update Posted : August 6, 2014
Sponsor:
Information provided by (Responsible Party):
Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Tissue Perfusion Procedure: Flow rate Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimal Flow Rate During Cardiopulmonary Bypass
Study Start Date : May 2010
Estimated Primary Completion Date : December 2015

Arm Intervention/treatment
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



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



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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

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

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

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