Fluid Responsiveness Prediction Using Extra Systoles

NCT02520037 | Completed

• 1 other identifier: University of Aarhus
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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

Conditions

Fluid Responsiveness

Keywords

Fluid responsiveness; Volume responsiveness; Hemodynamics

Outcome Measures

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)

  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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients admitted to a University Hospital intensive care unit

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Philips Healthcare: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2015
• First Posted: August 11, 2015
• Study Start: June 15, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 10, 2017

Record last verified: 2016-05

Locations

DK (1)