Septic ShockNCT07136532
Prediction of Fluid Responsiveness in Paediatric Patients With Septic Shock Using Carotid Doppler Ultrasonography and Echocardiography
An observational study of Septic Shock and Echocardiography Guided Fluid Management, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Septic Shock, Echocardiography Guided Fluid Management
- What is being tested?
- echocardiography
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: o All Patients with septic shock admitted at the PICU during their fluid resuscitative phase during study time will be included.
Who may be able to join
- 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).
Show all 9Show fewer
- Suspected intracranial hypertension.
- Skin lesions or bandages at the sites of ultrasound or echo-cardiography examinations.
- Anatomical anomalies of the neck.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain shams university _faculty of medicine
Cairo
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 velocity time integral (VTI)variation in patients with septic shock during their fluid resuscitation phase as a reliable predictor of fluid responsiveness.
Read the 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:
- Laboratory:
- Complete blood count.
- Venous blood gases.
- C-reactive protein.
- Kidney function tests.
- Albumin.
- Serum lactate.
- Fibrinogen
- Serum electrolytes.
- Fibrinogen to albumin ratio
- 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)
- Being tested
- echocardiography
- Keywords
- pediatric septic shock, echocardiography, carotid doppler
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiographyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136532
- Sponsor's protocol ID
- MD07/2024/2025
- Status last verified
- May 2025
- First submitted
- 29 Jun 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33577247
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Fluid Responsiveness in Paediatric Patients With Septic Shock Using Carotid Doppler Ultrasonography and Echocardiography
- ClinicalTrials.gov ID
- NCT07136532
- Acronym / sponsor ID
- MD07/2024/2025
- Keywords
- pediatric septic shock, echocardiography, carotid doppler
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Laboratory:
- Complete blood count.
- Venous blood gases.
- C-reactive protein.
- Kidney function tests.
- Albumin.
- Serum lactate.
- Fibrinogen
- Serum electrolytes.
- Fibrinogen to albumin ratio
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pediatric patients with septic shock | – | Diagnostic Test: echocardiographyAll 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 |
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- o All Patients with septic shock admitted at the PICU during their fluid resuscitative phase during study time will be included.
Key inclusion criteria (9 listed)
- 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
- Acquired and congenital heart disease.
- Acquired and congenital renal disease.
- Vascular anomalies (e.g. arteriovenous malformation, aneurysm).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| echocardiographyEchocardiography 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. | Diagnostic test | pediatric patients with septic shock |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Background: PubMed 33577247Liteplo 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.
- Individual participant dataSharing planned: No
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Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock and Echocardiography Guided Fluid Management, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara sobhy selim, assistant lecturer (+2001008668418, SaraSobhy@med.asu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07136532, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.