Fluid Responsiveness Prediction Using Extra Systoles

Fluid Responsiveness Prediction Using Extra Systoles in Critically Ill Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02520037

Enrollment

Registered

2015-08-11

Start date

2015-06-15

Completion date

2016-11-01

Last updated

2017-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Responsiveness

Keywords

Fluid responsiveness, Volume responsiveness, Hemodynamics

Brief 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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Denmark

Outcome results