Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2025-12-25 @ 7:23 PM
Study NCT ID:
NCT07136532
Status:
RECRUITING
Last Update Posted:
2025-08-22
First Post:
2025-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prediction of Fluid Responsiveness in Paediatric Patients With Septic Shock Using Carotid Doppler Ultrasonography and Echocardiography
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
Prediction of Fluid Responsiveness in Paediatric Patients With Septic Shock Using Carotid Doppler Ultrasonography and Echocardiography
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to evaluate the role of carotid Doppler and Echocardiography as a predictor of fluid responsiveness in paediatric patients with septic shock.
and To evaluate the diagnostic accuracy of Aortic peak velocity and velocity time integral (VTI)variation in patients with septic shock during their fluid resuscitation phase as a reliable predictor of fluid responsiveness.
and To evaluate the diagnostic accuracy of Aortic peak velocity and velocity time integral (VTI)variation in patients with septic shock during their fluid resuscitation phase as a reliable predictor of fluid responsiveness.
Detailed Description:
The goal of this study is to evaluate the role of carotid Doppler and Echocardiography as a predictor of fluid responsiveness in paediatric patients with septic shock.
and To evaluate the diagnostic accuracy of Aortic peak velocity and VTI variation in patients with septic shock during their fluid resuscitation phase as a reliable predictor of fluid responsiveness.All patients included in the study will be evaluated clinically and radiologically at fluid resuscitative phase of septic shock after fluid resuscitation.
This evaluation will include:
• Clinical examination:
Clinical evaluation will be done initially and after fluid resuscitation:
* Vital data (systolic, diastolic, and mean blood pressure, heart rate, Temperature).
* Urine output, capillary perfusion time, Central venous pressure (CVP).
* Detailed physical examination (chest, heart, and abdomen). • Investigations:
A) Laboratory:
* Complete blood count.
* Venous blood gases.
* C-reactive protein.
* Kidney function tests.
* Albumin.
* Serum lactate.
* Fibrinogen
* Serum electrolytes.
* Fibrinogen to albumin ratio
B) Imaging:
Echocardiography (measurement of stroke volume, stroke volume index, cardiac index, systemic vascular resistance index, Aortic peak velocity and VTI variation,, inferior vena cava (IVC)collapsibility index and IVC distensibility index)
and To evaluate the diagnostic accuracy of Aortic peak velocity and VTI variation in patients with septic shock during their fluid resuscitation phase as a reliable predictor of fluid responsiveness.All patients included in the study will be evaluated clinically and radiologically at fluid resuscitative phase of septic shock after fluid resuscitation.
This evaluation will include:
• Clinical examination:
Clinical evaluation will be done initially and after fluid resuscitation:
* Vital data (systolic, diastolic, and mean blood pressure, heart rate, Temperature).
* Urine output, capillary perfusion time, Central venous pressure (CVP).
* Detailed physical examination (chest, heart, and abdomen). • Investigations:
A) Laboratory:
* Complete blood count.
* Venous blood gases.
* C-reactive protein.
* Kidney function tests.
* Albumin.
* Serum lactate.
* Fibrinogen
* Serum electrolytes.
* Fibrinogen to albumin ratio
B) Imaging:
Echocardiography (measurement of stroke volume, stroke volume index, cardiac index, systemic vascular resistance index, Aortic peak velocity and VTI variation,, inferior vena cava (IVC)collapsibility index and IVC distensibility index)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: