Prediction of Fluid Responsiveness in Paediatric Patients With Septic Shock Using Carotid Doppler Ultrasonography and Echocardiography

NCT07136532 | Recruiting

• 1 other identifier: MD07/2024/2025
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock; Echocardiography Guided Fluid Management

Keywords

pediatric septic shock; echocardiography; carotid doppler

Outcome Measures

Primary Outcomes (1)

• To evaluate the role of carotid Doppler and Echocardiography as a predictor of fluid responsiveness in paediatric patients with septic shock.

  we use carotid Doppler and Echocardiography to predict the fluid responsiveness in paediatric patients with septic shock.

  one year

Study Arms (1)

pediatric patients with septic shock

All patients admitted at Paediatric Intensive care unit (PICU) during the period of the study and met the inclusion criteria. * Sex: Both males and females. * Age: 1 month to 16 years. * Sample size: 50 patients with septic shock admitted at PICU. 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 • Investigations: A) Laboratory: * Complete blood count. * Venous blood gases. * C-reactive protein. * Kidney function tests. * Albumin. * Serum lactate. -Echocardiography (measurement of stroke volume, stroke volume index,cardiac index) \_carotid doppler ultrasonography

Diagnostic Test: echocardiography

Interventions

echocardiography DIAGNOSTIC_TEST

Echocardiography will be performed using the ultrasound system echocardiographic equipment (Siemens Advanced Clinical Ultrasound Systems Optimized Navigation (ACUSON) P500), carotid doppler ultrasonography (Carotid blood flow and Corrected flow time) by using the ultrasound system echocardiographic equipment (Siemens ACUSON P500) . Those measurements will be done at time zero and upon completion of fluid resuscitation . • Statistical Analysis: All data will be collected, tabulated, and statistically analysed using International Business Machines\_Statistical Package for the Social Sciences (IBM SPSS) version 27.

pediatric patients with septic shock

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

o All Patients with septic shock admitted at the PICU during their fluid resuscitative phase during study time will be included.

You may qualify if:

• Children aged 1 month to 16 years.
• Patients with septic shock admitted at the PICU during their fluid resuscitative phase were included.Septic shock was diagnosed according to phoenix sepsis score 2024

You may not qualify if:

• Acquired and congenital heart disease.
• Acquired and congenital renal disease.
• Vascular anomalies (e.g. arteriovenous malformation, aneurysm).
• Suspected intracranial hypertension.
• Skin lesions or bandages at the sites of ultrasound or echo-cardiography examinations.
• Anatomical anomalies of the neck.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university _faculty of medicine

Cairo, Egypt

RECRUITING

Related Publications (1)

• Liteplo AS, Schleifer J, Marill KA, Huang CK, Gouker SK, Ratanski D, Diamond E, Filbin MR, Shokoohi H. Carotid Ultrasound in Assessing Fluid Responsiveness in Patients with Hypotension and Suspected Sepsis. Shock. 2021 Sep 1;56(3):419-424. doi: 10.1097/SHK.0000000000001755.

  PMID: 33577247 BACKGROUND

MeSH Terms

Conditions

Shock, Septic

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Central Study Contacts

Sara sobhy selim, assistant lecturer

CONTACT

+2001008668418; SaraSobhy@med.asu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: August 22, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)