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NCT Number: NCT07136532

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

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.

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Key information

Age range

1 month–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain shams university _faculty of medicine

Cairo, Egypt

Location status: Recruiting

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Exclusion criteria:
  • 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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: one year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sara sobhy selim, assistant lecturer

CONTACT

[email protected]

+2001008668418

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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