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Clinical Trials/NCT04298931
NCT04298931
Completed
Not Applicable

Fluid Responsiveness Prediction Using Pulse Pressure Variation - Integrating Ventilator Settings

University of Aarhus1 site in 1 country52 target enrollmentMay 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypovolemia
Sponsor
University of Aarhus
Enrollment
52
Locations
1
Primary Endpoint
>10% Increase in stroke volume from before to after a fluid bolus. (Fluid responsiveness)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

It is well known, that patients with circulatory impairment sometimes, but not always, benefit from intravenous fluids. Predicting if a fluid administration will improve circulation is therefore of substantial clinical interest.

Ventilator treatment induces cyclic variation in blood pressure due to interaction between the lungs and the heart. This variation is minor, but its amplitude may be used for guiding fluid administration.

However, this method of using ventilator-induced variation in blood pressure to predict the effect of fluid administration was developed when different settings for ventilator treatment was recommended, compared with today. With today's recommend ventilator treatment, the method is, unfortunately, less reliable.

The investigators will investigate how different ventilator settings influence variation in blood pressure, and the investigators will test if this knowledge allows us to better predict the effect of a fluid administration, by taking the ventilator settings into account.

Registry
clinicaltrials.gov
Start Date
May 15, 2020
End Date
June 29, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Scheduled open abdominal surgery.
  • Scheduled treatment with Aarhus University Hospital's goal-directed therapy protocol (hemodynamic monitoring).

Exclusion Criteria

  • Left ventricular ejection fraction ≤ 40 %
  • Irregular heart rhythm (e.g. atrial fibrillation or frequent ectopic beats)
  • Known right ventricular dysfunction (if reported qualitatively in pre-operative assessment or objectively via Tricuspid Annular Plane Systolic Excursion (TAPSE) \< 17 mm)
  • Pregnancy
  • Prior participation in this study

Outcomes

Primary Outcomes

>10% Increase in stroke volume from before to after a fluid bolus. (Fluid responsiveness)

Time Frame: From two minutes before to two minutes after a fluid administration.

A patient is considered a fluid responder if they have a \>10% increase in stroke volume (pulse contour analysis by the Edwards EV1000 with a FloTrac sensor). Pre-fluid stroke volume is calculated as the median stroke volume estimate in the two minutes immediately preceding the fluid bolus. Post-fluid stroke volume is calculated as the median stroke volume estimate in the two minutes immediately following the fluid bolus. Change in stroke volume is calculated as: 100% \* (Post-fluid stroke volume - Pre-fluid stroke volume) / Pre-fluid stroke volume

Study Sites (1)

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