Measurement of MSFP and Stressed Volume With CardioQ+®

Cardiac Surgery Clinical Trial

Official title:

Measurement of Mean Systemic Filling Pressure & Stressed Volume With CardioQ+® Oesophageal Doppler Measurement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03139929
• Other study ID #: NL 55531.018.15
• Status: Recruiting
• Start date: May 9, 2017
• Est. completion date: March 1, 2020

Study information

• Verified date: January 2020
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Denise Veelo, MD, PhD
• Phone: 020 566 9111
• Email: d.p.veelo[@]amc.uva.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To study the reliablity of MSFP and stressed volume to follow volume loading and to predict fload loading responsiveness in patients after elective coronary artery bypass grafting (CABG) surgery.

Description:

In this study the oesophageal Doppler monitor (CardioQ+), arterial pulse wave analysis (via the CardioQ+ and Flotrac device) and central venous pressure (CVP) will be used to estimate mean systemic filling pressure (MSFP) with the inspiratory hold method. Furthermore the MSFParm will be determined using a rapid cuff inflator. From MSFP vascular compliance (Csys) and stressed volume (Vs) will be calculated.

The accuracy of Vs to follow a 500 increase in volume will be studied. The accuracy of MSFP and Vs to to predict fluid loading responsiveness will be assessed in 42 patients after elective coronary artery bypass grafting (CABG) surgery. The effect of a standardised fluid loading on parameters of intrinsic contractility and afterload will be determined. The effect of fluid loading on inertia, resistance and elastance will be assessed

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: March 1, 2020
• Est. primary completion date: May 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients 18 years and older planned for CABG

Exclusion Criteria:

• Contraindication for fluid loading

• Pregnancy, morbid obesity

• Hemodynamic instability with a mean arterial pressure (MAP) < 55 mm Hg and/ or a cardiac index < 1.5 L•min-1

• Severe arrhythmias

• Intra-cardiac shunts

• Symptomatic peripheral vascular disease

• Symptomatic pulmonary disease

• Significant valvular regurgitation

• Poor pre-operative left or right ventricular function

• Core temperature < 36 °C

• Contra-indication to the rapid cuff inflator

• Contra-indication to oesophageal Doppler probe insertion.

Related Conditions & MeSH terms

• CABG
• Cardiac Surgery

Intervention

Diagnostic Test:
• MSFP
MSFPhold and MSFParm

Locations

Country	Name	City	State
Netherlands	Academic Medical Center Amsterdam	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vascular compliance (Csys)	Vascular compliance	Before and after fluid administration (2 minutes and 10 minutes)
Other	CVP	central venous pressure	Before and after fluid administration (2 minutes and 10 minutes)
Other	PPV	pulse pressure variation	Before and after fluid administration (2 minutes and 10 minutes)
Other	SVV	stroke volume variation	Before and after fluid administration (2 minutes and 10 minutes)
Other	Kinetic energy	Kinetic energy	Before and after fluid administration (2 minutes and 10 minutes)
Primary	MSFPhold	Mean systemic filling pressure	Before and after fluid administration (2 minutes and 10 minutes)
Primary	MSFParm	Mean systemic filling pressure	Before and after fluid administration (2 minutes and 10 minutes)
Secondary	Stressed volume	Vs	Before and after fluid administration (2 minutes and 10 minutes)