NCT03139929

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

May 9, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

April 3, 2017

Last Update Submit

January 9, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Stressed volume

    Before and after fluid administration (2 minutes and 10 minutes)

Other Outcomes (5)

  • Vascular compliance (Csys)

    Before and after fluid administration (2 minutes and 10 minutes)

  • CVP

    Before and after fluid administration (2 minutes and 10 minutes)

  • PPV

    Before and after fluid administration (2 minutes and 10 minutes)

  • +2 more other outcomes

Interventions

MSFPDIAGNOSTIC_TEST

MSFPhold and MSFParm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CABG

You may qualify if:

  • Patients 18 years and older planned for CABG

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Center Amsterdam

Amsterdam, Netherlands

RECRUITING

Related Publications (1)

  • 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.

Biospecimen

Blood samples

Study Officials

  • Bart Geerts, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise Veelo, MD, PhD

CONTACT

Alexander Vlaar, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

April 3, 2017

First Posted

May 4, 2017

Study Start

May 9, 2017

Primary Completion

May 5, 2019

Study Completion

March 1, 2020

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations