Measurement of MSFP and Stressed Volume With CardioQ+®

NCT ID: NCT03139929

Last Updated: 2020-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-09

Study Completion Date

2020-03-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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Cardiac Surgery CABG

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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MSFP

MSFPhold and MSFParm

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role lead

Responsible Party

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D.P.Veelo

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bart Geerts, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Locations

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Academic Medical Center Amsterdam

Amsterdam, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Denise Veelo, MD, PhD

Role: CONTACT

020 566 9111 ext. 66478

Alexander Vlaar, MD, PhD

Role: CONTACT

020 566 9111 ext. 66304

Facility Contacts

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Bart Geerts, MD, PhD

Role: primary

References

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Wijnberge M, Jansen JRC, Pinsky MR, Klanderman RB, Terwindt LE, Bosboom JJ, Lemmers N, Vlaar AP, Veelo DP, Geerts BF. Feasibility to estimate mean systemic filling pressure with inspiratory holds at the bedside. Front Physiol. 2022 Nov 29;13:1041730. doi: 10.3389/fphys.2022.1041730. eCollection 2022.

Reference Type DERIVED
PMID: 36523553 (View on PubMed)

Other Identifiers

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NL 55531.018.15

Identifier Type: -

Identifier Source: org_study_id

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