<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03755843</url>
  </required_header>
  <id_info>
    <org_study_id>DI/17/112/03/039</org_study_id>
    <nct_id>NCT03755843</nct_id>
  </id_info>
  <brief_title>PREDICTION OF FLUID RESPONSIVENESS WITH PASSIVE LEG RISING IN PREGNANT PATIENTS WITH SEVERE PREECLAMPSIA</brief_title>
  <official_title>PREDICTION OF FLUID RESPONSIVENESS WITH PASSIVE LEG RISING IN PREGNANT PATIENTS WITH SEVERE PREECLAMPSIA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RAUL CARRILLO ESPER</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Grupo Mexicano para el Estudio de la Medicina Intensiva</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      BACKGROUND: A cornerstone of treatment in preeclampsia is to correct the potential&#xD;
      hypovolemia with intravascular optimisation, which is usually performed as a fluid challenge.&#xD;
      The prediction of fluid responsiveness in these patients, secondary to anatomical and&#xD;
      physiological changes associated with pregnancy has not been established. This study aims to&#xD;
      evaluate if Passive Leg Raising (PLR) protocol can predict fluid responsiveness in pregnant&#xD;
      patients with severe preeclampsia.&#xD;
&#xD;
      MATERIALS AND METHODS: in 35 pregnant women diagnosed with preeclampsia with a clinical&#xD;
      indication to optimise intravascular volume, . A PLR manoeuvre and a fluid challenge will be&#xD;
      performed, and hemodynamic parameters were recorded using Bioreactance technology.&#xD;
      Descriptive statistical analyses, Pearson chi-square test, and mean standard deviation (SD)&#xD;
      will be calculated. Analysis of proportion was used to calculate probabilistic intersections&#xD;
      of the interventions. The area under curve, sensitivity, specificity, positive predictive&#xD;
      value and negative predictive value were calculated for a delta of 12.&#xD;
&#xD;
      Objective: to evaluate the if passive leg rising protocol identifies fluid responsivness in&#xD;
      pregnant patients with preeclampsia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION The clinical manifestations of preeclampsia (PE) are the consequence of&#xD;
      endothelial dysfunction. [1, 2] Different hemodynamic patterns have been described, which&#xD;
      includes: high vascular resistance, cardiac output (CO) alterations, relative hypovolemia,&#xD;
      and increased risk for pulmonary oedema, [3-6] which has been recognised as the most common&#xD;
      final cause of death in women with complications of hypertension7. The risk of pulmonary&#xD;
      oedema in preeclampsia is caused by different pathophysiological changes that follow the&#xD;
      disease. It can be classified as increase preload caused by iatrogenic resuscitation and&#xD;
      resolving puerperal oedema. Cardiac causes such as the presence of a myopathic ventricle,&#xD;
      diastolic dysfunction, valvular heart disease, increased afterload caused by severe&#xD;
      hypertension and increased vascular resistance, and other factors such as reduced oncotic&#xD;
      pressure increased capillary permeability or a combination of all.&#xD;
&#xD;
      A cornerstone of treatment to correct the potential hypovolemia in preeclampsia is&#xD;
      intravascular volume optimization, which usually is performed as a fluid challenge, [8-9]&#xD;
      However, the increased risk of pulmonary oedema has made us understand the need to use&#xD;
      dynamic hemodynamic parameters for fluid responsiveness to guide optimal intravascular volume&#xD;
      optimization in this group of patients.&#xD;
&#xD;
      Monitoring fluid therapy upon clinical observation or the estimation of filling pressures&#xD;
      using clinical markers such as blood pressure, pulse rate and urinary output as an endpoint&#xD;
      of euvolemia may be inaccurate in women with severe preeclampsia. In critically ill settings&#xD;
      the resolution of severe hypovolaemia is accompanied by rising blood pressure, falling of&#xD;
      pulse rate and increasing the urinary output. However, in preeclamptic women, oliguria may&#xD;
      develop because of intrinsic renal disease and may not respond to plasma volume expansion&#xD;
      with an increase of urinary output. [20] Tachycardia commonly complicates severe&#xD;
      preeclampsia, and a persistently rapid pulse rate may not be a reliable indication of&#xD;
      intravascular volume depletion, especially when the systolic blood pressure is within&#xD;
      reasonable limits.&#xD;
&#xD;
      In the intensive care unit, patients with spontaneous ventilation, an increase of stroke&#xD;
      volume during passive leg raising (PLR) predicts fluid responsiveness. [10-13] However,&#xD;
      during pregnancy, the validity of PLR has been questioned, secondary to the known anatomical&#xD;
      changes that occur from the compression of the inferior vena cava (IVC) by the gravid uterus&#xD;
      and the presence of increased abdominal pressure. [14-16] However recently Brun20 published&#xD;
      the first study that showed that PLR accurately predicts fluid responsiveness in the setting&#xD;
      of Severe Preeclampsia.&#xD;
&#xD;
      Thoracic bioreactance technology, [17] which is based on the analysis of thoracic voltage&#xD;
      amplitude changes in response to a high-frequency injected current, and has the potential to&#xD;
      be a useful noninvasive clinical tool for monitoring hemodynamics in pregnant women. However,&#xD;
      the prediction of fluid responsiveness in these patients, secondary to anatomical and&#xD;
      physiological changes associated with pregnancy has not been established.&#xD;
&#xD;
      The objective of this protocol is to evaluate if PLR test can predict fluid responsiveness in&#xD;
      pregnant patients with severe preeclampsia.&#xD;
&#xD;
      MATERIALS AND METHODS The study is approved by the Institutional Review Board. Both ethic and&#xD;
      research committee approved the protocol with registers number DI/17/112/03/039. Patients&#xD;
      will be informed and signed consent before participation. Patients are going to be&#xD;
      prospectively assessed, and consecutive measurements will be performed in an obstetric ICU of&#xD;
      Mexico´s General Hospital Dr Eduardo Liceaga from December 2016 to July 2017. A sample was&#xD;
      calculated for known variance P .01. Measurements for blood pressure and heart rate are made&#xD;
      using bioreactance (NICOMTM Panamedical Mexico City, Mexico) technology.[18] The monitor will&#xD;
      be placed at bedside, to monitor Systolic Arterial Pressure (SAP) and Diastolic Arterial&#xD;
      Pressure (DAP), Stroke Volume (SV), Stroke Volume Index (IVS), Cardiac Output (CO) and&#xD;
      Cardiac Index (CI).18 Because hemodynamic values may vary within a respiratory cycle,[17] an&#xD;
      average of 10 consecutive cardiac cycles, over at least one respiratory cycle, was used for&#xD;
      measurements of SAP, DAP, MAP, SV, and ISV.&#xD;
&#xD;
      Moreover, we use the best dynamic index report under those 10 minutes. A PLR manoeuvre was&#xD;
      performed for 3 minutes. The manoeuvre involved elevating the patient's legs and placing them&#xD;
      on an inflatable leg wedge providing an angle of 45 degrees while in the supine position.&#xD;
      Next, a 250 crystalloid /colloid (Hartmann + albumin 25%) bolus was given recording the same&#xD;
      hemodynamic parameters to observe changes in dynamic measurements to compare both results and&#xD;
      classified them as responder and non-responder. No determination or Central Venous Pressure&#xD;
      or surrogate was made because of the accumulative evidence of the failure of this methods to&#xD;
      detect changes in intravascular volume status. A change of 12% after PLR and bolus was used&#xD;
      to consider a patient responder[20]. Finally, we used the values for ISV because it would be&#xD;
      the better parameter (without the influence of heart rate and independent of the body area).&#xD;
&#xD;
      STATISTICAL ANALYSIS Using SPSS 23 statistics Descriptive data analysis of patients will be&#xD;
      performed for this purpose, a multivariable database will be constructed, and descriptive&#xD;
      statistical analyses made. To evaluate the distribution between variables a Pearson&#xD;
      chi-square test will be used. Mean standard deviation (SD) values, and analysis of proportion&#xD;
      with the aim of knowing the probabilistic intersections. The area under the curve,&#xD;
      sensitivity, specificity, negative predictive and positive predictive value will be&#xD;
      calculated for 12 for ISV.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Actual">May 15, 2018</completion_date>
  <primary_completion_date type="Actual">July 31, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Passive Leg Rising</measure>
    <time_frame>6 months</time_frame>
    <description>evaluate if PLR test can predict fluid responsiveness in pregnant patients with severe</description>
  </primary_outcome>
  <enrollment type="Actual">35</enrollment>
  <condition>Pre-Eclampsia</condition>
  <condition>Volume Overload</condition>
  <condition>Hemodynamic Instability</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>PASSIVE LEG RISING</intervention_name>
    <description>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.&#xD;
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</description>
    <other_name>fluid challenge</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Female pregnant women with sever preeclampsia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        second and thrith trimestrer Pregnant women with severe preeclampsia Non intubated&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Amputation of any limb heart or valve disease Chronic renal failure Chronic Liver failure&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>second a thirth pregnant women</gender_description>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital General de Mexico</name>
      <address>
        <city>Mexico City</city>
        <zip>06720</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <reference>
    <citation>Duley L. The global impact of pre-eclampsia and eclampsia. Semin Perinatol. 2009 Jun;33(3):130-7. doi: 10.1053/j.semperi.2009.02.010.</citation>
    <PMID>19464502</PMID>
  </reference>
  <reference>
    <citation>Sibai B, Dekker G, Kupferminc M. Pre-eclampsia. Lancet. 2005 Feb 26-Mar 4;365(9461):785-99. doi: 10.1016/S0140-6736(05)17987-2.</citation>
    <PMID>15733721</PMID>
  </reference>
  <reference>
    <citation>Young P, Johanson R. Haemodynamic, invasive and echocardiographic monitoring in the hypertensive parturient. Best Pract Res Clin Obstet Gynaecol. 2001 Aug;15(4):605-22. doi: 10.1053/beog.2001.0203. Erratum In: Best Pract Res Clin Obstet Gynaecol 2001 Oct;15(5):817.</citation>
    <PMID>11478818</PMID>
  </reference>
  <reference>
    <citation>Barton JR, Sibai BM. Life-threatening emergencies in preeclampsia-eclampsia. J Ky Med Assoc. 2006 Sep;104(9):410-8. No abstract available.</citation>
    <PMID>17100119</PMID>
  </reference>
  <reference>
    <citation>Sciscione AC, Ivester T, Largoza M, Manley J, Shlossman P, Colmorgen GH. Acute pulmonary edema in pregnancy. Obstet Gynecol. 2003 Mar;101(3):511-5. doi: 10.1016/s0029-7844(02)02733-3.</citation>
    <PMID>12636955</PMID>
  </reference>
  <reference>
    <citation>Societe francaise d'anesthesie et de reanimation (Sfar); College national des gynecologues et obstetriciens francais (CNGOF); Societe francaise de medecine perinatale (SFMP); Societe francaise de neonatalogie (SFNN). [Multidisciplinary management of severe pre-eclampsia (PE). Experts' guidelines 2008. Societe francaise d'anesthesie et de reanimation. College national des gynecologues et obstetriciens francais. Societe francaise de medecine perinatale. Societe francaise de neonatalogie]. Ann Fr Anesth Reanim. 2009 Mar;28(3):275-81. doi: 10.1016/j.annfar.2009.02.015. Epub 2009 Mar 24. No abstract available. French.</citation>
    <PMID>19321292</PMID>
  </reference>
  <reference>
    <citation>Sibai BM, Mabie BC, Harvey CJ, Gonzalez AR. Pulmonary edema in severe preeclampsia-eclampsia: analysis of thirty-seven consecutive cases. Am J Obstet Gynecol. 1987 May;156(5):1174-9. doi: 10.1016/0002-9378(87)90135-9.</citation>
    <PMID>3578433</PMID>
  </reference>
  <results_reference>
    <citation>Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. doi: 10.1378/chest.121.6.2000.</citation>
    <PMID>12065368</PMID>
  </results_reference>
  <results_reference>
    <citation>Monnet X, Teboul JL. Passive leg raising. Intensive Care Med. 2008 Apr;34(4):659-63. doi: 10.1007/s00134-008-0994-y. Epub 2008 Jan 23.</citation>
    <PMID>18214429</PMID>
  </results_reference>
  <results_reference>
    <citation>Monnet X, Rienzo M, Osman D, Anguel N, Richard C, Pinsky MR, Teboul JL. Passive leg raising predicts fluid responsiveness in the critically ill. Crit Care Med. 2006 May;34(5):1402-7. doi: 10.1097/01.CCM.0000215453.11735.06.</citation>
    <PMID>16540963</PMID>
  </results_reference>
  <results_reference>
    <citation>Brun C, Zieleskiewicz L, Textoris J, Muller L, Bellefleur JP, Antonini F, Tourret M, Ortega D, Vellin A, Lefrant JY, Boubli L, Bretelle F, Martin C, Leone M. Prediction of fluid responsiveness in severe preeclamptic patients with oliguria. Intensive Care Med. 2013 Apr;39(4):593-600. doi: 10.1007/s00134-012-2770-2. Epub 2012 Dec 6.</citation>
    <PMID>23223774</PMID>
  </results_reference>
  <results_reference>
    <citation>Vartun A, Flo K, Acharya G. Effect of passive leg raising on systemic hemodynamics of pregnant women: a dynamic assessment of maternal cardiovascular function at 22-24 weeks of gestation. PLoS One. 2014 Apr 14;9(4):e94629. doi: 10.1371/journal.pone.0094629. eCollection 2014.</citation>
    <PMID>24732308</PMID>
  </results_reference>
  <results_reference>
    <citation>Marques NR, Martinello C, Kramer GC, Costantine MM, Vadhera RB, Saade GR, Hankins GD, Pacheco LD. Passive leg raising during pregnancy. Am J Perinatol. 2015 Mar;32(4):393-8. doi: 10.1055/s-0034-1389089. Epub 2014 Sep 21.</citation>
    <PMID>25241109</PMID>
  </results_reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Grupo Mexicano para el Estudio de la Medicina Intensiva</investigator_affiliation>
    <investigator_full_name>RAUL CARRILLO ESPER</investigator_full_name>
    <investigator_title>GMEMI coordinator</investigator_title>
  </responsible_party>
  <keyword>passive leg risging</keyword>
  <keyword>Fluid challenge</keyword>
  <keyword>Preeclampsia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pre-Eclampsia</mesh_term>
    <mesh_term>Eclampsia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>February 19, 2019</submitted>
    <returned>May 16, 2019</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03755843
org study id: DI/17/112/03/039
nct id: NCT03755843
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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
INTRODUCTION The clinical manifestations of preeclampsia (PE) are the consequence of
      endothelial dysfunction. [1, 2] Different hemodynamic patterns have been described, which
      includes: high vascular resistance, cardiac output (CO) alterations, relative hypovolemia,
      and increased risk for pulmonary oedema, [3-6] which has been recognised as the most common
      final cause of death in women with complications of hypertension7. The risk of pulmonary
      oedema in preeclampsia is caused by different pathophysiological changes that follow the
      disease. It can be classified as increase preload caused by iatrogenic resuscitation and
      resolving puerperal oedema. Cardiac causes such as the presence of a myopathic ventricle,
      diastolic dysfunction, valvular heart disease, increased afterload caused by severe
      hypertension and increased vascular resistance, and other factors such as reduced oncotic
      pressure increased capillary permeability or a combination of all.

      A cornerstone of treatment to correct the potential hypovolemia in preeclampsia is
      intravascular volume optimization, which usually is performed as a fluid challenge, [8-9]
      However, the increased risk of pulmonary oedema has made us understand the need to use
      dynamic hemodynamic parameters for fluid responsiveness to guide optimal intravascular volume
      optimization in this group of patients.

      Monitoring fluid therapy upon clinical observation or the estimation of filling pressures
      using clinical markers such as blood pressure, pulse rate and urinary output as an endpoint
      of euvolemia may be inaccurate in women with severe preeclampsia. In critically ill settings
      the resolution of severe hypovolaemia is accompanied by rising blood pressure, falling of
      pulse rate and increasing the urinary output. However, in preeclamptic women, oliguria may
      develop because of intrinsic renal disease and may not respond to plasma volume expansion
      with an increase of urinary output. [20] Tachycardia commonly complicates severe
      preeclampsia, and a persistently rapid pulse rate may not be a reliable indication of
      intravascular volume depletion, especially when the systolic blood pressure is within
      reasonable limits.

      In the intensive care unit, patients with spontaneous ventilation, an increase of stroke
      volume during passive leg raising (PLR) predicts fluid responsiveness. [10-13] However,
      during pregnancy, the validity of PLR has been questioned, secondary to the known anatomical
      changes that occur from the compression of the inferior vena cava (IVC) by the gravid uterus
      and the presence of increased abdominal pressure. [14-16] However recently Brun20 published
      the first study that showed that PLR accurately predicts fluid responsiveness in the setting
      of Severe Preeclampsia.

      Thoracic bioreactance technology, [17] which is based on the analysis of thoracic voltage
      amplitude changes in response to a high-frequency injected current, and has the potential to
      be a useful noninvasive clinical tool for monitoring hemodynamics in pregnant women. However,
      the prediction of fluid responsiveness in these patients, secondary to anatomical and
      physiological changes associated with pregnancy has not been established.

      The objective of this protocol is to evaluate if PLR test can predict fluid responsiveness in
      pregnant patients with severe preeclampsia.

      MATERIALS AND METHODS The study is approved by the Institutional Review Board. Both ethic and
      research committee approved the protocol with registers number DI/17/112/03/039. Patients
      will be informed and signed consent before participation. Patients are going to be
      prospectively assessed, and consecutive measurements will be performed in an obstetric ICU of
      Mexico´s General Hospital Dr Eduardo Liceaga from December 2016 to July 2017. A sample was
      calculated for known variance P .01. Measurements for blood pressure and heart rate are made
      using bioreactance (NICOMTM Panamedical Mexico City, Mexico) technology.[18] The monitor will
      be placed at bedside, to monitor Systolic Arterial Pressure (SAP) and Diastolic Arterial
      Pressure (DAP), Stroke Volume (SV), Stroke Volume Index (IVS), Cardiac Output (CO) and
      Cardiac Index (CI).18 Because hemodynamic values may vary within a respiratory cycle,[17] an
      average of 10 consecutive cardiac cycles, over at least one respiratory cycle, was used for
      measurements of SAP, DAP, MAP, SV, and ISV.

      Moreover, we use the best dynamic index report under those 10 minutes. A PLR manoeuvre was
      performed for 3 minutes. The manoeuvre involved elevating the patient's legs and placing them
      on an inflatable leg wedge providing an angle of 45 degrees while in the supine position.
      Next, a 250 crystalloid /colloid (Hartmann + albumin 25%) bolus was given recording the same
      hemodynamic parameters to observe changes in dynamic measurements to compare both results and
      classified them as responder and non-responder. No determination or Central Venous Pressure
      or surrogate was made because of the accumulative evidence of the failure of this methods to
      detect changes in intravascular volume status. A change of 12% after PLR and bolus was used
      to consider a patient responder[20]. Finally, we used the values for ISV because it would be
      the better parameter (without the influence of heart rate and independent of the body area).

      STATISTICAL ANALYSIS Using SPSS 23 statistics Descriptive data analysis of patients will be
      performed for this purpose, a multivariable database will be constructed, and descriptive
      statistical analyses made. To evaluate the distribution between variables a Pearson
      chi-square test will be used. Mean standard deviation (SD) values, and analysis of proportion
      with the aim of knowing the probabilistic intersections. The area under the curve,
      sensitivity, specificity, negative predictive and positive predictive value will be
      calculated for 12 for ISV.
observational model: Cohort
time perspective: Prospective
measure: Passive Leg Rising
time frame: 6 months
description: evaluate if PLR test can predict fluid responsiveness in pregnant patients with severe
intervention type: Diagnostic Test
intervention name: PASSIVE LEG RISING
description: 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
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: second a thirth pregnant women
minimum age: 15 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
country: Mexico
citation: Duley L. The global impact of pre-eclampsia and eclampsia. Semin Perinatol. 2009 Jun;33(3):130-7. doi: 10.1053/j.semperi.2009.02.010.
PMID: 19464502
citation: Sibai B, Dekker G, Kupferminc M. Pre-eclampsia. Lancet. 2005 Feb 26-Mar 4;365(9461):785-99. doi: 10.1016/S0140-6736(05)17987-2.
PMID: 15733721
citation: Young P, Johanson R. Haemodynamic, invasive and echocardiographic monitoring in the hypertensive parturient. Best Pract Res Clin Obstet Gynaecol. 2001 Aug;15(4):605-22. doi: 10.1053/beog.2001.0203. Erratum In: Best Pract Res Clin Obstet Gynaecol 2001 Oct;15(5):817.
PMID: 11478818
citation: Barton JR, Sibai BM. Life-threatening emergencies in preeclampsia-eclampsia. J Ky Med Assoc. 2006 Sep;104(9):410-8. No abstract available.
PMID: 17100119
citation: Sciscione AC, Ivester T, Largoza M, Manley J, Shlossman P, Colmorgen GH. Acute pulmonary edema in pregnancy. Obstet Gynecol. 2003 Mar;101(3):511-5. doi: 10.1016/s0029-7844(02)02733-3.
PMID: 12636955
citation: Societe francaise d'anesthesie et de reanimation (Sfar); College national des gynecologues et obstetriciens francais (CNGOF); Societe francaise de medecine perinatale (SFMP); Societe francaise de neonatalogie (SFNN). [Multidisciplinary management of severe pre-eclampsia (PE). Experts' guidelines 2008. Societe francaise d'anesthesie et de reanimation. College national des gynecologues et obstetriciens francais. Societe francaise de medecine perinatale. Societe francaise de neonatalogie]. Ann Fr Anesth Reanim. 2009 Mar;28(3):275-81. doi: 10.1016/j.annfar.2009.02.015. Epub 2009 Mar 24. No abstract available. French.
PMID: 19321292
citation: Sibai BM, Mabie BC, Harvey CJ, Gonzalez AR. Pulmonary edema in severe preeclampsia-eclampsia: analysis of thirty-seven consecutive cases. Am J Obstet Gynecol. 1987 May;156(5):1174-9. doi: 10.1016/0002-9378(87)90135-9.
PMID: 3578433
citation: Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. doi: 10.1378/chest.121.6.2000.
PMID: 12065368
citation: Monnet X, Teboul JL. Passive leg raising. Intensive Care Med. 2008 Apr;34(4):659-63. doi: 10.1007/s00134-008-0994-y. Epub 2008 Jan 23.
PMID: 18214429
citation: Monnet X, Rienzo M, Osman D, Anguel N, Richard C, Pinsky MR, Teboul JL. Passive leg raising predicts fluid responsiveness in the critically ill. Crit Care Med. 2006 May;34(5):1402-7. doi: 10.1097/01.CCM.0000215453.11735.06.
PMID: 16540963
citation: Brun C, Zieleskiewicz L, Textoris J, Muller L, Bellefleur JP, Antonini F, Tourret M, Ortega D, Vellin A, Lefrant JY, Boubli L, Bretelle F, Martin C, Leone M. Prediction of fluid responsiveness in severe preeclamptic patients with oliguria. Intensive Care Med. 2013 Apr;39(4):593-600. doi: 10.1007/s00134-012-2770-2. Epub 2012 Dec 6.
PMID: 23223774
citation: Vartun A, Flo K, Acharya G. Effect of passive leg raising on systemic hemodynamics of pregnant women: a dynamic assessment of maternal cardiovascular function at 22-24 weeks of gestation. PLoS One. 2014 Apr 14;9(4):e94629. doi: 10.1371/journal.pone.0094629. eCollection 2014.
PMID: 24732308
citation: Marques NR, Martinello C, Kramer GC, Costantine MM, Vadhera RB, Saade GR, Hankins GD, Pacheco LD. Passive leg raising during pregnancy. Am J Perinatol. 2015 Mar;32(4):393-8. doi: 10.1055/s-0034-1389089. Epub 2014 Sep 21.
PMID: 25241109
responsible party type: Sponsor-Investigator
investigator affiliation: Grupo Mexicano para el Estudio de la Medicina Intensiva
investigator full name: RAUL CARRILLO ESPER
investigator title: GMEMI coordinator
mesh term: Pre-Eclampsia
mesh term: Eclampsia
sharing ipd: No
submitted: February 19, 2019
returned: May 16, 2019