Stroke Volume Analysis During Aortic Valve Replacement Trial

NCT02156856 | Unknown

• 1 other identifier: EA1/060/13
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamic Monitoring; Cardiac Output; Cardiac Surgery

Keywords

hemodynamic monitoring; cardiac output; cardiac surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

• 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

• 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

Other Outcomes (8)

• oxygen delivery (ml)

  Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks

• image quality of echocardiography

  Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks

• Length of stay on ICU

  participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Study Arms (2)

Hemodynamic optimisation

No hemodynamic optimisation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cardiac surgery at a university hospital

You may qualify if:

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

You may not qualify if:

• pregnant or breast-feeding women
• emergency surgery

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité Universitätsmedizin Berin

Berlin, State of Berlin, 10117, Germany

RECRUITING

Study Officials

• Michael Sander, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Sander, MD

CONTACT

+4930450531052; michael.sander@charite.de

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr. med.

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: June 5, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2015
• Last Updated: August 8, 2014

Record last verified: 2014-08

Locations

DE (1)