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Recruiting NCT07136532

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

— Observational Septic Shock Echocardiography Guided Fluid Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: echocardiography.
Who it may be relevant to
Registry conditions: Septic Shock, Echocardiography Guided Fluid Management. Basic parameters: 1 months — 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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)

Interventions

  • Diagnostic test echocardiography
    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 statist

Primary outcome measures

  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Ain shams university _faculty of medicine — Cairo

Publications

  • 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

Identifiers

NCT: NCT07136532 · MD07/2024/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗