Measurement of MSFP and Stressed Volume With CardioQ+®

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

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.

Study Overview

• Status: Unknown
• Conditions: CABG; Cardiac Surgery
• Intervention / Treatment: Diagnostic test: MSFP

Detailed 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

• Study Type: Observational
• Enrollment (Anticipated): 42

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Academic Medical Center Amsterdam
    • Contact: Bart Geerts, MD, PhD; Email: b.f.geerts@amc.uva.nl
    • Sub-Investigator: Marije Wijnberge, MD
    • Sub-Investigator: Alexander Vlaar, MD,PhD
    • Sub-Investigator: Denise Veelo, MD, PhD
    • Principal Investigator: Bart Geerts, MD, PhD

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

CABG

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MSFPhold	Mean systemic filling pressure	Before and after fluid administration (2 minutes and 10 minutes)
MSFParm	Mean systemic filling pressure	Before and after fluid administration (2 minutes and 10 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stressed volume	Vs	Before and after fluid administration (2 minutes and 10 minutes)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vascular compliance (Csys)	Vascular compliance	Before and after fluid administration (2 minutes and 10 minutes)
CVP	central venous pressure	Before and after fluid administration (2 minutes and 10 minutes)
PPV	pulse pressure variation	Before and after fluid administration (2 minutes and 10 minutes)
SVV	stroke volume variation	Before and after fluid administration (2 minutes and 10 minutes)
Kinetic energy	Kinetic energy	Before and after fluid administration (2 minutes and 10 minutes)

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Bart Geerts, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 9, 2017
• Primary Completion (ACTUAL): May 5, 2019
• Study Completion (ANTICIPATED): March 1, 2020

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (ACTUAL): May 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: NL 55531.018.15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No