Best Cardiac Output During Cardiopulmonary Bypass

Bypass Complications Clinical Trial

Official title:

Best Cardiac Output During Cardiopulmonary Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01379638
• Other study ID #: N-20080035
• Status: Completed
• Phase: N/A
• First received: June 22, 2011
• Last updated: June 22, 2011
• Start date: December 2008
• Est. completion date: January 2010

Study information

• Verified date: December 2008
• Source: Aalborg Universitetshospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine whether the patients cardiac output measured before cardiopulmonary bypass (CPB), is more sufficient to secure the patients oxygen needs than the estimated cardiac output from Ficks principle, and thereby prevent organ failure.

Description:

For more than 50 years, CPB has been used to mechanically support the functions of the heart and lungs. In early studies, systemic oxygen uptake, calculated using Ficks global principle, was used to assess the efficiency of CPB. Using this measure of efficiency, a pump flow rate in liters per minute, based on the product of the body surface area (BSA) and a constant of 2.4 was found adequate to perfuse the body during normothermia. Ficks global principle is still used together with other methods to secure adequated perfusion under CPB.

The purpose of this study is to determine whether the patients cardiac output measured before CPB, is more sufficient to secure the patients oxygen needs than the estimated cardiac output from Ficks principle, and thereby prevent organ failure.

The hypothesis is that the patients cardiac output is a better marker for the optimal cardiac output than the estimated cardiac output.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• patients admitted for scheduled cardiac surgery during cardiopulmonary bypass

• Aged 18-90 years

• LVEF > 50 %

• written consent from the patients

Exclusion Criteria:

• Former cerebral emboli

• Former head trauma

• known stenosis of the arteria carotis

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bypass Complications

Locations

Country	Name	City	State
Denmark	Alborg Hospital	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg Universitetshospital

Country where clinical trial is conducted

Denmark,