CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 286 enrolled
Drug / intervention
Fluid loading of 500 mL of crystalloid solution +1 moreother
Likely dose
Fluid loading of 500 mL of crystalloid solutionfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03225378
NCT03225378N/ACompleted

Changes in Pulse Pressure Variations Induced by Passive Leg Raising Test to Predict Fluid Responsiveness in ICU

Centre Hospitalier Arras·observational·Posted Jul 21, 2017·Updated Oct 27, 2021

In Brief

An observational study evaluating Fluid loading of 500 mL of crystalloid solution and Passive Leg Raising test for Acute Circulatory Failure. Completed, enrolled 286 participants across 12 sites.

Detailed Summary

The passive leg raising (PLR) test is a reversible preload challenge of around 300 mL of blood that can be repeated as frequently as required without infusing a drop of fluid. Two recent meta-analyses of many studies have confirmed the reliability of the PLR test to predict fluid responsiveness in patients with acute circulatory failure. Nevertheless, the effects of the PLR must be assessed by the direct measurement of cardiac output since changes in arterial pressure do not allow the assessment of the PLR hemodynamic effects with reliability. Moreover, cardiac output must be measured continuously and in real time. In clinical practice, cardiac output measurement can be difficult for different reasons such as the unavailability of the echocardiography machine, or the absence of any continuous cardiac output monitoring technique at the time of acute circulatory failure occurrence. Recently, it was shown that the decrease in pulse pressure variation (PPV) induced by the mini-fluid challenge (100 mL of colloid solution infused in 1 min) was able to predict fluid responsiveness with reliability in patients ventilated with low tidal volume (\<8 mL/kg of ideal body weight). Therefore, the investigators hypothesize that the changes in PPV induced by PLR test could be able to predict fluid responsiveness with reliability in mechanically ventilated patients with acute circulatory failure.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJul 21, 2017
Enrollment StartSep 21, 2017
Primary CompletionSep 20, 2021
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 8.9 years ago

Interventions

Fluid loading of 500 mL of crystalloid solutionother

Infusion of 500 mL of crystalloid solution in less than 15 minutes

Passive Leg Raising testother

This intervention is done before the fluid loading in order to predict fluid responsiveness.