Optimal Flow Rate During Cardiopulmonary Bypass
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2010
CompletedFirst Posted
Study publicly available on registry
April 16, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedAugust 6, 2014
August 1, 2014
5.6 years
April 15, 2010
August 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Microcirulation
measurement with O2C
intraooperative
Study Arms (1)
Flow rate
OTHERComparison between a flow rate of 2.5/l/min/m2 versus 3.0/l/min/m2
Interventions
Eligibility Criteria
You may qualify if:
- Extracorporeal circulation
- Age \> 18
- Written consent
You may not qualify if:
- Emergency cases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johann Wolfgang Goethe University Hospital
Frankfurt am Main, 60590, Germany
Related Links
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head cardiovascular research
Study Record Dates
First Submitted
April 15, 2010
First Posted
April 16, 2010
Study Start
May 1, 2010
Primary Completion
December 1, 2015
Last Updated
August 6, 2014
Record last verified: 2014-08