SepsisNCT07507877
Infraclavicular Axillary Vein Collapsibility Index as a Predictor of Fluid Responsiveness
An observational study of Sepsis, run by Ain Shams University at 1 site in Egypt.
Trial summary
Fluid responsiveness refers to the ability of the left ventricle to significantly increase stroke volume following fluid administration, and its assessment is critical in managing acute circulatory failure while avoiding fluid overload.Infraclavicular axillary vein collapsibility index is a substitute for inferior… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Infraclavicular axillary vein collapsibility index
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Apr 2026to 4 Nov 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Patients with sepsis must meet at least two or more criteria of systemic inflammatory response syndrome (SIRS). * Spontaneously breathing patients. * Clinical signs of acute circulatory failure.
Who may be able to join
- Adult patients ≥18 years.
- Patients with sepsis must meet at least two or more criteria of systemic inflammatory response syndrome (SIRS).
- Spontaneously breathing patients.
- Clinical signs of acute circulatory failure.
Who cannot join
- Patients below the age of 18 years.
- Mechanically ventilated patients
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 Hospitals
Cairo
Ibrahim Mamdouh Esmat, 01001241928, ibrahim_mamdouh@med.asu.edu.eg
About this study
Official title: Infraclavicular Axillary Vein Collapsibility Index as a Predictor of Fluid Responsiveness in Spontaneously Breathing Patients in Sepsis-related Acute Circulatory Failure: a Prospective Observational Study
Fluid responsiveness refers to the ability of the left ventricle to significantly increase stroke volume following fluid administration, and its assessment is critical in managing acute circulatory failure while avoiding fluid overload.Infraclavicular axillary vein collapsibility index is a substitute for inferior vena cava collapsibility index in assessment for the need of fluid resuscitation in spontaneously breathing sepsis related acute circulatory failure patients.
- Conditions
- Sepsis
- Being tested
- Infraclavicular axillary vein collapsibility index
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infraclavicular axillary vein collapsibility indexOther
Assessment of the infraclavicular axillary vein collapsibility index to predict fluid responsiveness in spontaneously breathing patients in sepsis related acute circulatory failure.
What is being measured
The primary outcome is the main question the study is designed to answer.
The infraclavicular axillary vein collapsibility index changes in response to fluid challenge.
The infraclavicular axillary vein collapsibility index changes in response to fluid challenge. A collapsibility index greater than fifty percent in spontaneously breathing patients is commonly associated with a right atrial pressure between zero and five millimeters of mercury.
Measured: Fluid challenge over 10 min time period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start4 Apr 2026
- Primary completion4 Nov 2026 (estimated)
- Study completion4 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Mamdouh Esmat, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507877
- Sponsor's protocol ID
- FMASU-MS 257 / 2026
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infraclavicular Axillary Vein Collapsibility Index as a Predictor of Fluid Responsiveness in Spontaneously Breathing Patients in Sepsis-related Acute Circulatory Failure: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07507877
- Acronym / sponsor ID
- FMASU-MS 257 / 2026
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 4 Apr 2026 (actual)
- Primary completion
- 4 Nov 2026 (estimated)
- Study completion
- 4 Nov 2026 (estimated)
- First posted
- 2 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 responsiveness refers to the ability of the left ventricle to significantly increase stroke volume following fluid administration, and its assessment is critical in managing acute circulatory failure while avoiding fluid overload.Infraclavicular axillary vein collapsibility index is a substitute for inferior vena cava collapsibility index in assessment for the need of fluid resuscitation in spontaneously breathing sepsis related acute circulatory failure patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients with sepsis must meet at least two or more criteria of systemic inflammatory response syndrome (SIRS). * Spontaneously breathing patients. * Clinical signs of acute circulatory failure.
Key inclusion criteria (4 listed)
- Adult patients ≥18 years.
- Patients with sepsis must meet at least two or more criteria of systemic inflammatory response syndrome (SIRS).
- Spontaneously breathing patients.
- Clinical signs of acute circulatory failure.
Key exclusion criteria (2 listed)
- Patients below the age of 18 years.
- Mechanically ventilated patients
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 |
|---|---|---|
| Infraclavicular axillary vein collapsibility indexAssessment of the infraclavicular axillary vein collapsibility index to predict fluid responsiveness in spontaneously breathing patients in sepsis related acute circulatory failure. | Other | – |
Primary outcome
The infraclavicular axillary vein collapsibility index changes in response to fluid challenge.
Time frame: Fluid challenge over 10 min time period.
The infraclavicular axillary vein collapsibility index changes in response to fluid challenge. A collapsibility index greater than fifty percent in spontaneously breathing patients is commonly associated with a right atrial pressure between zero and five millimeters of mercury.
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 15 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 Sepsis, 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 4 inclusion and 2 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 15 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 Ibrahim Mamdouh Esmat (01001241928, ibrahim_mamdouh@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The infraclavicular axillary vein collapsibility index changes in response to fluid challenge. (time frame: Fluid challenge over 10 min time period.). 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 15 Apr 2026.