Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527443
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Arterial Stiffness in Patients With Sepsis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Arterial Stiffness as a Predictor of Acute Kidney Injury in Patients With Sepsis
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To investigate whether arterial stiffness as defined by measuring Pulse Wave Velocity could be identified as an independent risk factor for development of acute kidney injury in sepsis
To compare between the Pulse Wave Velocity and shear wave ultrasound elastography SWE as a different methods of evaluation of arterial stiffness in prediction of acute kidney injury in sepsis
To compare between the Pulse Wave Velocity and shear wave ultrasound elastography SWE as a different methods of evaluation of arterial stiffness in prediction of acute kidney injury in sepsis
Detailed Description:
Demographic and historical data the patient age sex history of hypertension diabetes peripheral vascular disease IHD source of sepsis and indication of mechanical ventilation if indicated
Clinical examination data pulse blood pressure respiratory rate temperature and thorough chest cardiac and neurological examination data will be obtained
Volume state of the patient CVP measurement input and output fluid chart Investigation CBC Neutrophil count Neutrophillymphocyte ratio Blood urea and serum creatinine serum electrolytes serum lactateserum albuminCRP coagualtion profile and lipid profile sequential organ failure assessment SOFA score acute physiology and chronic health evaluation APACHE II score and complete sepsis workup to identify the possible sources of sepsis
12 lead ECG and Echocardiographic data that include Left and right atrial dimensions The left ventricular ejection fraction will be assessed by the Simpson method left ventricular diastolic function will be assessed by measuring velocities of the mitral E and A waves and of the e wave of the external mitral annulus and by calculating the Ee ratio Right ventricle dimension and dysfunction will be evaluated by TAPSE and pulmonary artery acceleration time Pulmonary artery pressure will be measured from Tricuspid flow if possible
Pulse Wave Velocity PWV a measurement of arterial stiffness will be assessed at the systemic region carotid-femoral PWV which is the gold standard method In the first 24 hours of admission
The two-dimensional SWE technique will be used in our study an imaging method will be obtained by simultaneously applying multiple ARFI waves into the tissue and measuring the resulting shear waves It will be assessed in the first 24 hours of admission
RRI will be measured at the time of admission All measurements will be performed by the same examiner and repeated by an independent blinded operator Using pulse-wave Doppler an interlobar or arcuate artery will be selected RRI will be calculated as the equation PSV-EDVPSV The means of three distinct RRI calculations will be recorded
Clinical examination data pulse blood pressure respiratory rate temperature and thorough chest cardiac and neurological examination data will be obtained
Volume state of the patient CVP measurement input and output fluid chart Investigation CBC Neutrophil count Neutrophillymphocyte ratio Blood urea and serum creatinine serum electrolytes serum lactateserum albuminCRP coagualtion profile and lipid profile sequential organ failure assessment SOFA score acute physiology and chronic health evaluation APACHE II score and complete sepsis workup to identify the possible sources of sepsis
12 lead ECG and Echocardiographic data that include Left and right atrial dimensions The left ventricular ejection fraction will be assessed by the Simpson method left ventricular diastolic function will be assessed by measuring velocities of the mitral E and A waves and of the e wave of the external mitral annulus and by calculating the Ee ratio Right ventricle dimension and dysfunction will be evaluated by TAPSE and pulmonary artery acceleration time Pulmonary artery pressure will be measured from Tricuspid flow if possible
Pulse Wave Velocity PWV a measurement of arterial stiffness will be assessed at the systemic region carotid-femoral PWV which is the gold standard method In the first 24 hours of admission
The two-dimensional SWE technique will be used in our study an imaging method will be obtained by simultaneously applying multiple ARFI waves into the tissue and measuring the resulting shear waves It will be assessed in the first 24 hours of admission
RRI will be measured at the time of admission All measurements will be performed by the same examiner and repeated by an independent blinded operator Using pulse-wave Doppler an interlobar or arcuate artery will be selected RRI will be calculated as the equation PSV-EDVPSV The means of three distinct RRI calculations will be recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None