Optimal Flow Rate During Cardiopulmonary Bypass

Tissue Perfusion Clinical Trial

Official title:

Optimal Flow Rate During Cardiopulmonary Bypass

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01105078
• Other study ID #: CI001AZ-AHK
• Status: Recruiting
• Phase: N/A
• First received: April 15, 2010
• Last updated: August 5, 2014
• Start date: May 2010

Study information

• Verified date: August 2014
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: Arndt H Kiessling, MD
• Phone: +49696301
• Email: arndt.kiessling[@]kgu.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Extracorporeal circulation

• Age > 18

• Written consent

Exclusion Criteria:

• Emergency cases

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tissue Perfusion

Intervention

Procedure:
• Flow rate
Different flow rate during cardiopulmonary bypass

Locations

Country	Name	City	State
Germany	Johann Wolfgang Goethe University Hospital	Frankfurt am Main

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microcirulation	measurement with O2C	intraooperative	Yes

External Links

•   Klinikum der Johann Wolfgang Goethe Universität Frankfurt aM Germany