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

NCT ID: NCT03755843

Last Updated: 2018-11-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-01
• Study Completion Date: 2018-05-15

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

Detailed Description

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.

Conditions

Pre-Eclampsia; Volume Overload; Hemodynamic Instability

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

fluid challenge

Eligibility 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

RAUL CARRILLO ESPER

OTHER

Sponsor Role: lead

Responsible Party

RAUL CARRILLO ESPER

GMEMI coordinator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hospital General de Mexico

Mexico City, , Mexico

Countries

Mexico

References

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Reference Type: RESULT

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Other Identifiers

DI/17/112/03/039

Identifier Type: -

Identifier Source: org_study_id