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Completed

NCT Number: NCT02520037

Fluid Responsiveness Prediction Using Extra Systoles

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

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Key information

Conditions

Fluid Responsiveness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital

Aarhus C, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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

    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)

    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)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Philips Healthcare

Registry information

Official study title

Fluid Responsiveness Prediction Using Extra Systoles in Critically Ill Patients

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 11, 2015
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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