CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 35 enrolled
Drug / intervention
PASSIVE LEG RISINGother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03755843
NCT03755843N/ACompleted

PREDICTION OF FLUID RESPONSIVENESS WITH PASSIVE LEG RISING IN PREGNANT PATIENTS WITH SEVERE PREECLAMPSIA

RAUL CARRILLO ESPER·observational·Posted Nov 28, 2018·Updated Nov 28, 2018

In Brief

An observational study evaluating PASSIVE LEG RISING for Pre-Eclampsia and 2 related conditions. Completed, enrolled 35 participants across 1 site.

Detailed Summary

BACKGROUND: A cornerstone of treatment in preeclampsia is to correct the potential hypovolemia with intravascular optimisation, which is usually performed as a fluid challenge. The prediction of fluid responsiveness in these patients, secondary to anatomical and physiological changes associated with pregnancy has not been established. This study aims to evaluate if Passive Leg Raising (PLR) protocol can predict fluid responsiveness in pregnant patients with severe preeclampsia. MATERIALS AND METHODS: in 35 pregnant women diagnosed with preeclampsia with a clinical indication to optimise intravascular volume, . A PLR manoeuvre and a fluid challenge will be performed, and hemodynamic parameters were recorded using Bioreactance technology. Descriptive statistical analyses, Pearson chi-square test, and mean standard deviation (SD) will be calculated. Analysis of proportion was used to calculate probabilistic intersections of the interventions. The area under curve, sensitivity, specificity, positive predictive value and negative predictive value were calculated for a delta of 12. Objective: to evaluate the if passive leg rising protocol identifies fluid responsivness in pregnant patients with preeclampsia

Study Details

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

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedNov 28, 2018
Enrollment StartDec 1, 2016
Primary CompletionJul 31, 2017
Study CompletionMay 15, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.6 years ago

Interventions

PASSIVE LEG RISINGother

Pasive Leg Rising: In the supine method, the legs are lifted passively from the horizontal position to a 30° to 45° elevation while the head of the bed is flat. Fluid Challenge: Fluid responsiveness is generally defined as an increase in SV or CO of 10% to 15% in response to a 250 mL crystalloid fluid bolus