Stroke Volume Analysis During Aortic Valve Replacement Trial

Cardiac Surgery Clinical Trial

— standart  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02156856
• Other study ID #: EA1/060/13
• Status: Recruiting
• Phase: N/A
• First received: May 20, 2014
• Last updated: August 7, 2014
• Start date: May 2014

Study information

• Verified date: August 2014
• Source: Charite University, Berlin, Germany
• Contact: Michael Sander, MD
• Phone: +4930450531052
• Email: michael.sander[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Output
• Cardiac Surgery
• Hemodynamic Monitoring

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	oxygen delivery (ml)		Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks	No
Other	image quality of echocardiography		Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks	No
Other	Length of stay on ICU		participants will be followed for the duration of hospital stay, an expected average of 2 weeks	No
Other	Cumulative rate of infections		after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks	No
Other	incidence of delirium after surgery		after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks	No
Other	dosage of inotropic medication (mg/d)		after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks	No
Other	length of hospital stay		after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks	No
Other	incidence of stroke		after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No