Clinical trial NCT05095974: Predictors of Pulmonary Edema in Severe Preeclampsia
Official title: Echocardiography, Thoracic Fluid Content and Lung Ultrasound Monitoring as Predictors of Pulmonary Edema in Severe Preeclampsia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Edema
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: After obtaining approval from the Medical Research Ethics Committee Faculty of medicine, Assiut University, Assiut, Egypt, this study will be done in ICU in Assiut University Woman Health Hospital . Written informed consents will be obtained from all participants, after reading the patient information sheet and describing the procedure to the participants

Brief summary: Pre-eclampsia is a multisystem major cardiovascular disease of pregnancy with hypertension its main clinical manifestation. Acute pulmonary edema, which signifies severe disease, is a leading cause of death in women with pre-eclampsia, and is a frequent cause for admission to an intensive care unit

Detailed description: Outside pregnancy, transthoracic cardiac ultrasound (echocardiography) and lung ultrasound have become important diagnostic and monitoring tools in critically ill patients. Echocardiography allows a rapid and non-invasive assessment of myocardial contractility and preload, and lung ultrasound can be used to determine the amount of extravascular lung water (EVLW).

In pregnancy, there is evidence of a good correlation between non-invasive hemodynamic monitoring by echocardiography and invasive monitoring using a pulmonary artery catheter. Previous studies have shown that invasive hemodynamic monitoring could facilitate fluid management in patients with PE. However, recent studies have examined the utility of echocardiography in combination with lung ultrasound for guiding fluid therapy in patients with severe PE.

Thoracic fluid content (TFC) is one of the many variables measured by the ICON electrical cardiometry (EC) device (Osypka Medical, etc.). The ICON device is one relatively new proprietary implementation of impedance cardiography technology, which is also often called "thoracic electrical bio-impedance". Impedance cardiography is based on measuring the changes in total resistance of the thorax to electric current. The impedance (Zo) to electric current is determined by the resistance of different tissues such as bone, muscles, and fluids. The fluid compartment is considered the dynamic component that will cause short term changes in thoracic impedance. TFC is calculated as the reciprocal of the total thoracic impedance (1/ Zo) and is considered a numerical measure of total (intravascular and extravascular) thoracic fluid. Although TFC is a measure of both extra and intra-vascular thoracic fluid, the investigators hypothesized that it might provide an estimate of the increase in intrathoracic fluids such as to facilitate the risk of pulmonary edema.

Eligibility criteria: Inclusion criteria :

Pregnant women with one or more of the following:

* new-onset cerebral or visual disturbances
* thrombocytopenia (platelet count \<100 000/mL)
* elevated liver enzymes (transaminases) to twice the normal upper limit;
* severe persistent pain in the right upper or middle upper abdomen that does not respond to medication and is not explained by another condition
* renal insufficiency (serum creatinine \>97 μmol/L), or a doubling of serum creatinine concentration in the absence of other renal disease
* systolic blood pressure ≥160mmHg or diastolic blood pressure ≥110mmHg on more than one occasion at least 4 h apart while the patient is on bed rest (unless antihypertensive therapy had been initiated before this time).

Exclusion Criteria:

* Age below 18 yr
* SP during the postpartum period
* refusal to participate to the study.
* history of cardiac or respiratory disease
* patients with clinical manifestations of pulmonary edema

Primary outcomes:
measure: detection of pulmonary edema
timeFrame: 4 days
Secondary outcomes:
measure: Echocardiography
timeFrame: 4 days
measure: Thoracic fluid content
timeFrame: 4 days
Other outcomes:
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