Using TEE to Evaluate the Effect of Levosimendan on Patients With ARDS Associated With RVD During MV
Trial · NCT05768230
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The rate of right ventricular dysfunction occurrence within 48 hours after randomization. | From the time point of enrollment to 48 hours after enrollment | Right ventricular dysfunction(RVD) is diagnosed when the results of an echocardiogram show one of the following, including: tricuspid annular plane systolic excursion(TAPSE)\<16 mm, right ventricular fractional area change(RV FAC)\<35% or systolic velocity of the lateral tricuspid valve annulus( RV S')\<10 cm/s. |
| Secondary | Right ventricular area fractional change (RV FAC) 48 hours after randomization | at the time of 48 hours after enrollment | Right ventricular area fractional change (RV FAC)is a simple and repeatable ultrasound method for evaluating RV function. Methods: The RV end-diastolic area (RVEDA) and RV end-systolic area (RVESA) were measured on the apical four-chamber section by two-dimensional ultrasound. RV FAC=(RVEDA- RVESA)/RVEDA\*100%. |
| Secondary | tricuspid annular plane systolic excursion(TAPSE) 48 hours after randomization | at the time of 48 hours after enrollment | TAPSE is one of the most effective ultrasound methods for evaluating right ventricular function.Measurement method: TAPSE was measured on the four-chamber section of the apex of the heart by M-mode ultrasound. the sampling line was placed at the side wall of the tricuspid valve ring, parallel to the free wall of the right ventricle as far as possible, and the displacement of the tricuspid valve ring was measured from the end of diastole to the end of systole. |
| Secondary | Tricuspid annular systolic S' velocity (TS') | at the time of 48 hours after enrollment | TS' is an objective and accurate ultrasound technique for evaluating right ventricular function.Measurement method:The sample volume was applied to the free wall of the RV and the peak velocity of tricuspid annulus motion was measured in the four-chamber section of the apex by tissue doppler imaging (TDI) |
| Secondary | Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA) | at the time of 48 hours after enrollment | RVEDA/LVEDA a simple and repeatable ultrasound method for evaluating dynamics changes of RV function.Methods: The RV end-diastolic area (RVEDA) and left ventricular(LV) end-systolic area (LVEDA) were measured on the apical four-chamber section by two-dimensional ultrasound |
| Secondary | Pulmonary circulatory resistance (PVR) | at the time of 48 hours after enrollment | Increased PVR can lead to deterioration of RV function.Pulse Doppler imaging (PWD) was used to obtain the pulmonary artery flow spectrum from the pulmonic valve on the short axial section of the parasternal great vessels. |
| Secondary | Sequential Organ Failure Assessment score | at the time of 48 hours after enrollment | The higher the Sequential Organ Failure Assessment(SOFA) score, the higher the disease risk factor and the higher the mortality rate(The highest score is 24, while the lowest score is 0). |
| Secondary | cardiac index(CI) patients | at the time of 48 hours after enrollment | CI is an important parameter to reflect the cardiac function of |
| Secondary | Central venous oxygen saturation(ScvO2) | at the time of 48 hours after enrollment | The patient's blood was collected through a central venous catheter for blood gas analysis to calculate SCVO2 to indicate tissue perfusion |
| Secondary | systemic vascular resistance(SVR) | at the time of 48 hours after enrollment | Peripheral vascular resistance is an important indicator of hemodynamics. It is not only a parameter reflecting cardiac afterload, but also a quantitative indicator reflecting the degree of patency of cerebrovascular microcirculation. |
| Secondary | Mean arterial pressure (MAP) | at the time of 48 hours after enrollment | MAP represents peripheral organ perfusion pressure. |
| Secondary | Central venous pressure(CVP) | at the time of 48 hours after enrollment | CVP is the pressure of the upper and lower vena cava entering the right atrium, measured by the upper and lower vena cava or the internal tube of the right atrium, which reflects the pressure of the right atrium, and is one of the main indicators for clinical observation of hemodynamics |
| Secondary | systemic vascular resistance index(SVRI) | at the time of 48 hours after enrollment | SVRI=80\*(MAP-CVP)/CI |
| Secondary | 28-day mortality | Day 28 after study entry | 28-day mortality after study entry |
| Secondary | in-hospital mortality | From the day patients admitted to hospital to the day death or discharge(up to 90 days) | Any death occurred during hospitalization(up to 90 days) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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