Fluid Responsiveness Prediction Using Extra Systoles

Fluid Responsiveness Prediction Using Extra Systoles in Critically Ill Patients

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

Study Overview

• Status: Completed
• Conditions: Fluid Responsiveness

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• Denmark
  • Aarhus C, Denmark, 8000
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients admitted to a University Hospital intensive care unit

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Philips Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: August 3, 2015
• First Submitted That Met QC Criteria: August 6, 2015
• First Posted (Estimate): August 11, 2015

Study Record Updates

• Last Update Posted (Actual): February 10, 2017
• Last Update Submitted That Met QC Criteria: February 9, 2017
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Fluid responsiveness; Hemodynamics; Volume responsiveness
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Cardiac Complexes, Premature
• Other Study ID Numbers: University of Aarhus