Stroke Volume Analysis During Aortic Valve Replacement Trial

• Conditions: Cardiac Output; Cardiac Surgery; Hemodynamic Monitoring

• Registration Number: NCT02156856
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

Compromised peripheral tissue oxygenation during surgery may lead to worse patient outcome, mainly due to post-operative infections or heart failure. Insufficient stroke volume and/or cardiac output due to hypovolemia or cardiac defects play a central role in causing poor peripheral tissue oxygenation. In order to assess stroke volume, there are numerous invasive and non-invasive methods available. Up to the present date it is unknown, if these methods may by used interchangeably in patients with severe cardiac defects like aortic stenosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-20
• Study First Submitted QC: 2014-06-02
• Study First Posted: 2014-06-05
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-07
• Last Update Posted: 2014-08-08
• Primary Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• scheduled transcatheter aortic valve implantation
• signed patient consent form
• aged 18 or older by time of surgery
• no participation in other clinical trials

Exclusion Criteria

• pregnant or breast-feeding women
• emergency surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of stroke volume (ml) before TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography, (3) pulmonary thermodilution via pulmonary artery catheter	Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Measurement of cardiac output (l/min) before TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography, (3) pulmonary thermodilution via pulmonary artery catheter	Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcome Measures

Name	Time	Method
Measurement of stroke volume (ml) after TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter	After surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Measurement of cardiac output (l/min) after TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter	After Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Accordance of stroke volume and cardiac output measurements assessed by (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter AFTER ADMINISTRATION OF FLUID BOLUS	Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Accordance of stroke volume and cardiac output measurements assessed by two of the mentioned methods [i.e. (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter]	Before and after Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Trial Locations

Locations (1)

Charité Universitätsmedizin Berin; 🇩🇪 Berlin, Germany