PREDICTION OF FLUID RESPONSIVENESS WITH PASSIVE LEG RISING IN PREGNANT PATIENTS WITH SEVERE PREECLAMPSIA
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03755843|
Recruitment Status : Completed
First Posted : November 28, 2018
Last Update Posted : November 28, 2018
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
|Condition or disease||Intervention/treatment|
|Pre-Eclampsia Volume Overload Hemodynamic Instability||Diagnostic Test: PASSIVE LEG RISING|
Show Detailed Description
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||35 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||PREDICTION OF FLUID RESPONSIVENESS WITH PASSIVE LEG RISING IN PREGNANT PATIENTS WITH SEVERE PREECLAMPSIA|
|Actual Study Start Date :||December 1, 2016|
|Actual Primary Completion Date :||July 31, 2017|
|Actual Study Completion Date :||May 15, 2018|
- Diagnostic Test: PASSIVE LEG RISING
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 bolusOther Name: fluid challenge
- Passive Leg Rising [ Time Frame: 6 months ]evaluate if PLR test can predict fluid responsiveness in pregnant patients with severe
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03755843
|Hospital General de Mexico|
|Mexico City, Mexico, 06720|