Clinical trial NCT02156856: Stroke Volume Analysis During Aortic Valve Replacement Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemodynamic Monitoring
Cardiac Output
Cardiac Surgery
Keywords: hemodynamic monitoring
cardiac output
cardiac surgery
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2014-06-05
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiac surgery at a university hospital

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: 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
timeFrame: Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes:
measure: 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
timeFrame: After surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: 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
timeFrame: Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: 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]
timeFrame: Before and after Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: 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
timeFrame: After Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Other outcomes:
measure: oxygen delivery (ml)
timeFrame: Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: image quality of echocardiography
timeFrame: Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Length of stay on ICU
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Cumulative rate of infections
timeFrame: after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: incidence of delirium after surgery
timeFrame: after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: dosage of inotropic medication (mg/d)
timeFrame: after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: length of hospital stay
timeFrame: after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: incidence of stroke
timeFrame: after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Michael Sander, MD
role: PRINCIPAL_INVESTIGATOR
References: