Fluid Responsiveness Prediction Using Extra Systoles

Fluid Responsiveness Clinical Trial

Official title:

Fluid Responsiveness Prediction Using Extra Systoles in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02520037
• Other study ID #: University of Aarhus
• Status: Completed
• Phase: N/A
• First received: August 3, 2015
• Last updated: February 9, 2017
• Start date: June 15, 2015
• Est. completion date: November 1, 2016

Study information

• Verified date: May 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 1, 2016
• Est. primary completion date: November 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fluid Responsiveness

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus C

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Philips Healthcare

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)