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CompletedNCT02520037Updated Feb 10, 2017

Fluid Responsiveness Prediction Using Extra Systoles

An observational study in Fluid Responsiveness, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-10.

Sponsored by University of Aarhus · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
26
Ages
18 Years and older
Sex
All
01

Study summary

Fluids are generally administered to patients in order to improve circulation. However, fluids do not always improve circulation and fluids have side effects. Unfortunately, it is difficult to predict whether fluid administration improves the circulation, i.e. it is difficult to predict fluid responsiveness The overall aim of this observational study is to investigate if analysis of spontaneously occuring extra systoles can give the answer: The second beat in the extra systole - the post ectopic beat - is a normal sinus beat but it has experienced the compensatory pause, i.e. this beat is associated with increased filling time and in turn associated with increased filling. As such, the post ectopic beat shows how the heart responds to increased filling. Therefore, the hypothesis of this study is that the hemodynamic response to the increased filling at the post ectopic beat (compared with sinus beats) can predict fluid responsiveness

02

Conditions studied

  • Fluid Responsiveness

Keywords

  • Fluid responsiveness
  • Volume responsiveness
  • Hemodynamics
03

In context

Cardiac Complexes, Premature

79 studies on the registry are indexed under Cardiac Complexes, Premature; 13 are open to participants now.

This study's enrollment of 26 is below the median of 100 across 37 observational studies indexed under Cardiac Complexes, Premature.

Browse Cardiac Complexes, Premature studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Critically ill patients admitted to a University Hospital intensive care unit

Inclusion criteria

  • Patients scheduled for a 500 ml volume expansion
  • Patients without atrial fibrillation
  • Patients equipped with ECG, arterial pressure and non-invasive cardiac output monitoring

Exclusion criteria

Exclusion Criteria:

  • Changes in anesthetic, vasoactive or inotropic drugs during the study period (30 minutes before fluid infusion initiation to end of fluid infusion).
  • Changes in positive end-expiratory pressure the study period
  • Changes in bed positioning the study period
  • Infusion time with crystalloids exceeding 30 minutes
  • Infusion time with colloids exceeding 75 minutes
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
26 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Change in stroke volume (SV) following fluid administration. A positive fluid response is defined as a 15% or more increase in SV

    A positive fluid response is defined as a 15% or more increase in SV. From the arterial pressure curve, post ectopic changes (comparing with 10 preceding sinus beats) in systolic blood pressure and pre-ejection period will be derived and used to predict the fluid response. Time frame used is the 30 minutes prior to the volume expansion (from t = -30 min to t = 0 min)

    Time frame: Change in SV from immediately before fluid infusion (t=0 min) to immediately after fluid administration (t < 30 min for crystalloid infusions; t < 75 min for colloid infusions)

07

Study locations

1 site
  • Aarhus University Hospital
    Aarhus C, 8000, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02520037
Lead sponsor
University of Aarhus
Collaborators
Philips Healthcare
Responsible party
Sponsor
First posted
Aug 11, 2015
Start date
Jun 15, 2015
Primary completion
Nov 1, 2016
Completion
Nov 1, 2016
Last update
Feb 10, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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