An observational study in Septic Shock, sponsored by Assiut University. Terminated at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-01-30.
Sponsored by Assiut University · Observational
Introduction Aim of the work Patients and methods Type of study Exclusion criteria Statistical analysis Research ethics Reference
Septic shock is a serious infectious condition characterized by low blood pressure and multiple organ damage. One of the traditional recommendations is to administer intravenous fluids as the first step to improve blood pressure(1).
However, studies have shown that not every patient benefits from aggressive intravenous hydration (2).
Previous studies have shown that certain parameters may correlate with volume status and others may not to correlate with patient volume status.
Hemodynamic parameters, such as stroke volume variation (SVV) and pleth variability index (PVI) may better predict fluid responsiveness. However, assessments of these parameters require invasive procedures and special monitoring equipment, which limits their clinical application (4).
Echocardiography has been widely adopted to diagnose and monitor cardiac dysfunction leading to hemodynamic instability, and shock pathophysiology in general.
However, the echocardiographic information on macro-hemodynamics is partial, especially as being indirect as concerns vascular tone, and not allowing any inference on end-organ perfusion (5).
Recently, ultrasonography for estimating volume status has been widely recommended because of its non-invasive nature, ease of acquisition, and reproducibility of measurements.
The inferior vena cava (IVC) is a compliant vessel whose size and shape vary with changes in CVP and intravascular volume. Therefore, sonographic measurement of the IVC represents an effective and non-invasive method of estimating CVP.
Respiratory variation in the IVC diameter was used as a guide for fluid therapy in septic shock in both spontaneous breathing and mechanically ventilated patients.
Moreover, the assessment of visceral end-organ perfusion by ultrasound, may offer insights into this facet of shock pathophysiology (5).
Among these ultrasound modalities, corrected flow time (FTc) measured in the carotid artery is a new approach for predicting fluid responsiveness that has shown promising results.
Therefore, although it is a dynamic index, it may be able to adequately evaluate volume status in spontaneously and mechanically breathing patients.
Aim of the work: 1- To evaluate whether carotid FTc as determined by Doppler ultrasound could be a predictor of fluid responsiveness in spontaneously breathing and mechanically ventilated patients.
2- To evaluate the predictive ability of ΔVpeak for fluid responsiveness in spontaneously breathing patients.
3- To detect changes of regional splanchnic hemodynamics by color Doppler resistive index, and its improvement after fluid administration.
4- To evaluate the predictive ability of IVC collapsibility and distensibility indices for fluid responsiveness in septic shock patients.
5- To compare between the predictive ability of the measured Ultrasonographic parameters and the CVP changes in response to intravenous fluid therapy in both spontaneously breathing and mechanically ventilated septic shock patients.
862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.
This study's enrollment of 45 is below the median of 100 across 298 observational studies indexed under Shock, Septic.
Browse Shock, Septic studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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After recording these data, the patients will be administered a fluid challenge of a 500 mL fluid bolus of 0.9% normal saline over 10 min and then same haemodynamic parameters will be measured again.
Fluid responsiveness is an increase of stroke volume of 10-15% by echocardiography, after the patient receives 500 ml of crystalloid over 10 min.
Exclusion Criteria:
* Carotid ultrasonography: Parameters will be measured by single blinded independent examiner using an ultrasound device. Baseline carotid FTc, ΔVpeak, will be measured. * Echocardiography: Stroke Volume will be measured by transthoracic echocardiography. * Renal and splenic Doppler resistivity index. * Inferior vena cava collapsibility and distensibility indices. * Central venous pressure estimation by central venous catheter, and central - Lung ultrasound for detection of lung congestion * Lung ultrasound for detection of lung congestion.
Ultrasonographic predictors of intravenous fluid responsiveness in septic shock and its correlation to central venous pressure
To evaluate whether carotid FTc as determined by Doppler ultrasound could be a predictor of fluid responsiveness in spontaneously breathing and MV patients.
Time frame: Baseline
Evaluation the predictive ability of ΔVpeak for fluid responsiveness in spontaneously breathing patients.
To evaluate the predictive ability of ΔVpeak for fluid responsiveness in spontaneously breathing patients. and the ΔVpeak will be calculated as follows: (maximum peak velocity - minimum peak velocity)/\[(maximum peak velocity + minimum peak velocity)/2\] × 100
Time frame: Baseline
Detection changes of regional splanchnic hemodynamics by color Doppler resistive index, and its improvement after fluid administration.
To detect changes of regional splanchnic hemodynamics by color Doppler resistive index, and its improvement after fluid administration. Resistive index (RI): (peak systolic velocity - end-diastolic velocity) / peak systolic velocity. The normal range is 0.50-0.70.
Time frame: Baseline
Plan to share: No
This study is terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Assiut University