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Trial record 26 of 152 for:    severe preeclampsia AND Pregnancy Complications

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

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ClinicalTrials.gov Identifier: NCT03755843
Recruitment Status : Completed
First Posted : November 28, 2018
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
RAUL CARRILLO ESPER, Grupo Mexicano para el Estudio de la Medicina Intensiva

Brief 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


Condition or disease Intervention/treatment
Pre-Eclampsia Volume Overload Hemodynamic Instability Diagnostic Test: PASSIVE LEG RISING

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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 bolus

    Other Name: fluid challenge


Primary Outcome Measures :
  1. Passive Leg Rising [ Time Frame: 6 months ]
    evaluate if PLR test can predict fluid responsiveness in pregnant patients with severe



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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   second a thirth pregnant women
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female pregnant women with sever preeclampsia
Criteria

Inclusion Criteria:

second and thrith trimestrer Pregnant women with severe preeclampsia Non intubated

Exclusion Criteria:

Amputation of any limb heart or valve disease Chronic renal failure Chronic Liver failure


Information from the National Library of Medicine

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


Locations
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Mexico
Hospital General de Mexico
Mexico City, Mexico, 06720
Sponsors and Collaborators
RAUL CARRILLO ESPER

Additional Information:

Publications of Results:
Other Publications:

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Responsible Party: RAUL CARRILLO ESPER, GMEMI coordinator, Grupo Mexicano para el Estudio de la Medicina Intensiva
ClinicalTrials.gov Identifier: NCT03755843     History of Changes
Other Study ID Numbers: DI/17/112/03/039
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RAUL CARRILLO ESPER, Grupo Mexicano para el Estudio de la Medicina Intensiva:
passive leg risging
Fluid challenge
Preeclampsia
Additional relevant MeSH terms:
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Pre-Eclampsia
Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications