Septic ShockNCT07550400
Role of Echocardiography and Ultrasound Indices in Resuscitation of Septic Shock Patients
An observational study of Septic Shock and Fluid Resuscitation, run by Ain Shams University at 1 site in Egypt.
Trial summary
Fluid replacement is considered the cornerstone of hemodynamic management in critically ill patients especially in patients with septic shock. However, only about 50% of critically ill hemodynamically unstable patients are responsive to fluids. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Septic Shock, Fluid Resuscitation
- What is being tested?
- carotid artery duplex and Left ventricular end diastolic area
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 3 May 2026to 12 Nov 2026
- How long will I take part?
- 1 Day
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: septic shock patients in ICU
Who may be able to join
- ▪ Age:18-50 years old
- Sex: both males \&females.
- Patients diagnosed with septic shock according to SOFA score more than or equal 1
- Presence of at least one sign of acute circulatory failure from:
- Low blood pressure (mean arterial pressure <65 mmHg and / or systolic <90 mmHg).
- Tachycardia> 120 bpm without other obvious cause of circulatory failure.
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- Oliguria <1 ml / kg during the last hour suggestive of circulatory failure.
- Blood hyperlactatemia > 2mmol / l without other obvious cause a systemic circulatory failure.
- Another sign justifying, for example vascular increase capillary refill time more than 2 seconds.
Who cannot join
- ▪ Known significant valvular heart disease (sever aortic insufficiency or stenosis)
- Known carotid artery stenosis >50% or previous carotid surgery
- Clear contraindication to the carotid artery Doppler such as wound or infection or complete or partial occlusion of the carotid artery.
- Arrhythmias affect stroke volume assessment (atrial fibrillation, frequent PVCs)
- Dilated cardiomyopathy.
- Poor transthoracic echocardiographic window
- Patient refusal
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
Faculty of medicine, Ain Shams University
Cairo
Rania Maher, +2-01000544520, raniamhm.rm@gmail.com
About this study
Official title: Echocardiographic Left Ventricular End Diastolic Area Versus Carotid Artery Duplex as a Sensitive Indicator for Guiding Fluid Resuscitation in Septic Shock Patients . A Prospective Cohort Study
Fluid replacement is considered the cornerstone of hemodynamic management in critically ill patients especially in patients with septic shock. However, only about 50% of critically ill hemodynamically unstable patients are responsive to fluids. Consequently, the resuscitation of critically ill patients requires an accurate assessment of the patients' intravascular volume status and their volume responsiveness. In this study, we will compare the efficacy of carotid artery flow to echo left ventricular end diastolic volume as a predictive value for fluid resuscitation in septic shock patients.
Read the detailed description
Fluid replacement is considered the cornerstone of hemodynamic management in critically ill patients especially in patients with septic shock. However, only about 50% of critically ill hemodynamically unstable patients are responsive to fluids. Consequently, the resuscitation of critically ill patients requires an accurate assessment of the patients' intravascular volume status and their volume responsiveness. In this study, we will compare the efficacy of carotid artery flow to echo left ventricular end diastolic volume as a predictive value for fluid resuscitation in septic shock patients.The Doppler study of carotid artery circulation (Velocity Time Integral, Peak Velocity) is simple and overpasses this common limitation among intensive care patients. Moreover, it showed to be an easy-learning tool The Velocity Time Integral (VTI) is a measurement of blood flow during systole that is passing through the left ventricular outflow tract (LVOT). The normal range for a VTI is 18-22 cm, values below this are suggestive of depressed cardiac output, an increase in the VTI is indicative of an increase in cardiac output. If a significant change in VTI 15% or more VTI0is observed after a fluid challenge, this would indicate that the patient is preload (fluid) responsive.
- Conditions
- Septic Shock, Fluid Resuscitation
- Being tested
- carotid artery duplex, Left ventricular end diastolic area
- Keywords
- End diastolic diameter, carotid artery duplex, septic shock
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carotid artery duplexProcedure or surgery
, Carotid Doppler (T0) will be performed within 1-2 Hours of ICU Admission to measure the following parameters: "Peak systolic velocity" and Velocity Time Integral over the common carotid artery. Using the linear probe (VF12-4) of ultrasound machine (ACUSON NX3, Siemens Medical solution USA, Inc.)
- According to surviving sepsis campaign guidelines 2021, patients diagnosed with septic shock should be given 30ml/kg IV crystalloid fluid within the first 3 hours, the fluid will be given in the form of 500 ml boluses, each bolus should be given in 15 minutes.
- FC "fluid challenge" will be performed by rapid volume infusion over (30minutes) of 1000mL Ringer acetate solution.
- Carotid artery Duplex parameters will be repeated. Relative changes in "Peak Systolic Velocity, Velocity Time integral" will be expressed in
Left ventricular end diastolic areaProcedure or surgery
- Echocardiography (T0) will be performed within 1-2 Hours of ICU Admission to measure LVEDA if less than 10 cm2 then the patient will be considered hypovolemic.
- According to surviving sepsis campaign guidelines 2021, patients diagnosed with septic shock should be given 30ml/kg IV crystalloid fluid within the first 3 hours, the fluid will be given in the form of 500 ml boluses, each bolus should be given in 15 minutes.
- FC "fluid challenge" will be performed by rapid volume infusion over (30minutes) of 1000mL Ringer acetate solution.
- After five minutes from FC "fluid challenge" (T1), echocardiography will be repeated to re-measure LVEDA. Pt will be defined as a responder if LVEDA b
| Study group | Role | What they receive |
|---|---|---|
| septic shock patients | septic shock according to SOFA score more than or equal 1 Receives: Procedure: carotid artery duplex; Procedure: Left ventricular end diastolic area |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of echo and ultrasound indices
Diagnostic accuracy (sensitivity, specificity) of LVEDA and carotid artery flow parameters (PEAK Systolic Velocity, Velocity time integral (VTI), in predicting fluid responsiveness defined as an increase in stroke volume after a standardized fluid challenge.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start3 May 2026 (estimated)
- Primary completion2 Nov 2026 (estimated)
- Study completion12 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 40 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550400
- Sponsor's protocol ID
- FMASU MD 240L2025
- Status last verified
- Sep 2025
- First submitted
- 18 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Left Ventricular End Diastolic Area Versus Carotid Artery Duplex as a Sensitive Indicator for Guiding Fluid Resuscitation in Septic Shock Patients . A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07550400
- Acronym / sponsor ID
- FMASU MD 240L2025
- Conditions
- Septic Shock, Fluid Resuscitation
- Keywords
- End diastolic diameter, carotid artery duplex, septic shock
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 3 May 2026 (estimated)
- Primary completion
- 2 Nov 2026 (estimated)
- Study completion
- 12 Nov 2026 (estimated)
- First posted
- 24 Apr 2026 (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.
Fluid replacement is considered the cornerstone of hemodynamic management in critically ill patients especially in patients with septic shock. However, only about 50% of critically ill hemodynamically unstable patients are responsive to fluids. Consequently, the resuscitation of critically ill patients requires an accurate assessment of the patients' intravascular volume status and their volume responsiveness. In this study, we will compare the efficacy of carotid artery flow to echo left ventricular end diastolic volume as a predictive value for fluid resuscitation in septic shock patients.
Detailed description
Fluid replacement is considered the cornerstone of hemodynamic management in critically ill patients especially in patients with septic shock. However, only about 50% of critically ill hemodynamically unstable patients are responsive to fluids. Consequently, the resuscitation of critically ill patients requires an accurate assessment of the patients' intravascular volume status and their volume responsiveness. In this study, we will compare the efficacy of carotid artery flow to echo left ventricular end diastolic volume as a predictive value for fluid resuscitation in septic shock patients.The Doppler study of carotid artery circulation (Velocity Time Integral, Peak Velocity) is simple and overpasses this common limitation among intensive care patients. Moreover, it showed to be an easy-learning tool The Velocity Time Integral (VTI) is a measurement of blood flow during systole that is passing through the left ventricular outflow tract (LVOT). The normal range for a VTI is 18-22 cm, values below this are suggestive of depressed cardiac output, an increase in the VTI is indicative of an increase in cardiac output. If a significant change in VTI 15% or more VTI0is observed after a fluid challenge, this would indicate that the patient is preload (fluid) responsive.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| septic shock patients | – | Procedure: carotid artery duplex, Procedure: Left ventricular end diastolic areaseptic shock according to SOFA score more than or equal 1 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- septic shock patients in ICU
Key inclusion criteria (9 listed)
- ▪ Age:18-50 years old
Key exclusion criteria (7 listed)
- ▪ Known significant valvular heart disease (sever aortic insufficiency or stenosis)
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 |
|---|---|---|
| carotid artery duplex, Carotid Doppler (T0) will be performed within 1-2 Hours of ICU Admission to measure the following parameters: "Peak systolic velocity" and Velocity Time Integral over the common carotid artery. Using the linear probe (VF12-4) of ultrasound machine (ACUSON NX3, Siemens Medical solution USA, Inc.) * According to surviving sepsis campaign guidelines 2021, patients diagnosed with septic shock should be given 30ml/kg IV crystalloid fluid within the first 3 hours, the fluid will be given in the form of 500 ml boluses, each bolus should be given in 15 minutes. * FC "fluid challenge" will be performed by rapid volume infusion over (30minutes) of 1000mL Ringer acetate solution. * Carotid artery Duplex parameters will be repeated. Relative changes in "Peak Systolic Velocity, Velocity Time integral" will be expressed in | Procedure or surgery | septic shock patients |
| Left ventricular end diastolic area* Echocardiography (T0) will be performed within 1-2 Hours of ICU Admission to measure LVEDA if less than 10 cm2 then the patient will be considered hypovolemic. * According to surviving sepsis campaign guidelines 2021, patients diagnosed with septic shock should be given 30ml/kg IV crystalloid fluid within the first 3 hours, the fluid will be given in the form of 500 ml boluses, each bolus should be given in 15 minutes. * FC "fluid challenge" will be performed by rapid volume infusion over (30minutes) of 1000mL Ringer acetate solution. * After five minutes from FC "fluid challenge" (T1), echocardiography will be repeated to re-measure LVEDA. Pt will be defined as a responder if LVEDA b | Procedure or surgery | septic shock patients |
Primary outcome
Accuracy of echo and ultrasound indices
Time frame: 1 Day
Diagnostic accuracy (sensitivity, specificity) of LVEDA and carotid artery flow parameters (PEAK Systolic Velocity, Velocity time integral (VTI), in predicting fluid responsiveness defined as an increase in stroke volume after a standardized fluid challenge.
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 24 Apr 2026.
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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 Fluid Resuscitation, 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 7 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 24 Apr 2026. 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 baheya kamel (+2-01115746487, baheya.hesham.kamel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of echo and ultrasound indices (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2026.