Stroke Volume Analysis During Aortic Valve Replacement Trial (standart)

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.

Study Overview

• Status: Unknown
• Conditions: Cardiac Surgery; Hemodynamic Monitoring; Cardiac Output

• Study Type: Observational
• Enrollment (Anticipated): 68

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Charité Universitätsmedizin Berin
    • Sub-Investigator: Felix Balzer, MD
    • Contact: Michael Sander, MD; Phone Number: +4930450531052; Email: michael.sander@charite.de
    • Sub-Investigator: Sascha Treskatsch, MD
    • Sub-Investigator: Marit Habicher, MD
    • Sub-Investigator: Viktor Mezger, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cardiac surgery at a university hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Hemodynamic optimisation
No hemodynamic optimisation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Cumulative rate of infections	after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
incidence of delirium after surgery	after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
dosage of inotropic medication (mg/d)	after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
length of hospital stay	after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
incidence of stroke	after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Michael Sander, MD, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): May 1, 2015

Study Registration Dates

• First Submitted: May 20, 2014
• First Submitted That Met QC Criteria: June 2, 2014
• First Posted (Estimate): June 5, 2014

Study Record Updates

• Last Update Posted (Estimate): August 8, 2014
• Last Update Submitted That Met QC Criteria: August 7, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: cardiac surgery; cardiac output; hemodynamic monitoring
• Other Study ID Numbers: EA1/060/13