Sepsis and Septic ShockNCT07516236
Dynamic SvO2 in Predicting Fluid Responsiveness in Septic Shock
An observational study of Sepsis and Septic Shock, run by Menoufia University at 1 site in Egypt.
Trial summary
This prospective observational diagnostic accuracy study investigates the efficacy of dynamic central venous oxygen saturation in predicting fluid responsiveness in septic shock, compared to measurements obtained using echocardiography (VTI) and cardiometry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis and Septic Shock
- What is being tested?
- Measuring dynamic central venous oxygen saturation (ScvO2) at baseline and after fluid challenge. Measuring Cardiac output by echocardiography or cardiometry at baseline and after fluid challenge.
- Type of treatment
- Medical device
- How many people
- 115 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2026to Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This single-center, prospective, observational study will be conducted in the Intensive Care Unit (ICU) at Menoufia University Hospitals. Adults spontaneously breathing patients with septic shock who undergo a fluid challenge as a part of their hemodynamic management in the first 24 hours will be eligible for enrollment. Ethical approval will be obtained from the ethics committee at the Menoufia Faculty of Medicine, and the study will follow ethical guidelines and secure approval from the Institutional Review Board (IRB). Written informed consent will be obtained from each participant or their legal surrogate before study inclusion.
Who may be able to join
- Age > 18 years
- Diagnosis of septic shock according to Sepsis-3 criteria:
- Suspected or confirmed infection o Requirement for vasopressors to maintain MAP > 65 mmHg o Serum lactate > 2 mmol/L despite adequate fluid resuscitation
Who cannot join
- Pregnancy
- Significant valvular heart disease.
- Atrial fibrillation.
- Inadequate echocardiographic window.
- Ongoing bleeding or contraindication to fluid bolus.
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
Menoufia University
Menouf
Menoufia U MenoufiaU, 01128861471, mostafanevine@gmail.com
About this study
Official title: Diagnostic Accuracy of Dynamic Central Venous Oxygen Saturation in Predicting Fluid Responsiveness in Septic Shock: A Prospective Observational Study
This prospective observational diagnostic accuracy study investigates the efficacy of dynamic central venous oxygen saturation in predicting fluid responsiveness in septic shock, compared to measurements obtained using echocardiography (VTI) and cardiometry. We will correlate the changes in measuring cardiac output by both echocardiography and cardiometry with the changes in dynamic central venous oxygen saturation both at baseline and after fluid challenge to investigate the efficacy of dynamic central venous oxygen saturation in predicting fluid responsiveness in septic shock.
Read the detailed description
All patients will undergo standardized monitoring to ensure accurate and reproducible hemodynamic assessment throughout the study period.
Blood pressure will be monitored noninvasively using an automated oscillometric cuff applied to the upper arm. MAP will be maintained at ≥65 mmHg with vasopressor support as required, and no changes in vasopressor infusion will be permitted during the measurement period.
A central venous catheter will be inserted in the internal jugular or subclavian vein, with the position confirmed by chest radiography. Central venous blood samples will be collected at baseline and after the fluid challenge for the determination of a Central venous oxygen saturation (ScvO₂).
Echocardiographic Assessment Left ventricular outflow tract (LVOT) diameter will be measured in the parasternal long-axis view by transthoracic echocardiography (Sonoscape S8 Echocardiography), and Doppler assessment of velocity- time integral (VTI) will be obtained in the apical five-chamber view. Stroke volume (SV) will be calculated as LVOT area × VTI, and values will be averaged from three consecutive cardiac cycles over a single respiratory cycle. The echocardiography operator will be an expert intensivist in echo operation (more than 7 years of experience), and the operator will be blinded to ScvO2.
Cardiac Output Monitoring (Electrical Cardiometry) Cardiac output will also be assessed noninvasively using a validated electrical cardiometry device (ICON®, Osypka Medical, Germany).
Parameters including stroke volume, cardiac output, and cardiac index will be documented at baseline and after the fluid challenge. Device calibration will be verified before each study session.
Timing of Measurements
Hemodynamic variables and oxygenation parameters will be recorded at two prespecified time points:
- Baseline - immediately prior to fluid challenge or passive leg raising maneuver.
- Post-intervention - within 5 minutes following intervention. Intervention A standardized fluid challenge protocol will be employed. Indications for fluid administration will include: Hypotension, defined as systolic blood pressure (SBP) ≤ 90 mmHg, a reduction in SBP ≥ 40 mmHg in patients with pre-existing hypertension, or mean arterial pressure (MAP) ≤ 65 mmHg, or evidence of tissue hypoperfusion, such as delayed capillary refill time, skin mottling, altered mental status, urine output ≤ 0.5 mL/kg/h for > 2 hours, or hyperlactatemia (> 2 mmol/L).
Eligible patients will receive a rapid infusion of 500 mL isotonic crystalloid solution ( normal saline) administered over a 15-minute period.
Throughout the intervention, all concomitant therapies-including background maintenance fluids, vasopressor or inotrope dosage, and mechanical ventilation settings-will remain unchanged to avoid confounding effects on hemodynamic measurements.
Definition of Fluid Responsiveness Fluid responsiveness will be defined as an increase in stroke volume index (derived from echocardiography or cardiometry) of ≥10- 15% after the intervention. This definition is consistent with established hemodynamic criteria and will serve as the reference standard for comparison with dynamic changes in ScvO₂. Stroke Volume Index (SVI) is the volume of blood pumped by the heart's ventricle with each beat, normalized to the individual's body surface area (BSA).
Data Collection For each patient, the following variables were systematically recorded: Baseline characteristics
- Demographic data (age, sex), and Comorbidities
- Source of infection
- Severity of illness scores:
- Acute Physiology and Chronic Health Evaluation II (APACHE II) o Sequential Organ Failure Assessment (SOFA)
- Life-support therapies as vasopressor use.
- Clinical outcomes (ICU length of stay, mortality) Hemodynamic and laboratory parameters Measured at two time points: immediately before the fluid challenge and within five minutes after completion.
- Heart rate (beats/min)
- Blood pressure
- Hemoglobin concentration (Hb, g/dL)
- Cardiac output (CO) by echocsardiography and electrical cardiometry
- Central venous blood gas analysis: Central venous oxygen saturation (ScvO₂)
- Conditions
- Sepsis and Septic Shock
- Being tested
- Measuring dynamic central venous oxygen saturation (ScvO2) at baseline and after fluid challenge. Measuring Cardiac output by echocardiography or cardiometry at baseline and after fluid challenge.
- Keywords
- Diagnostic Accuracy, Dynamic Venous Oxygen Saturation, Fluid Responsiveness, Septic Shock
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring dynamic central venous oxygen saturation (ScvO2) at baseline and after fluid challenge. Measuring Cardiac output by echocardiography or cardiometry at baseline and after fluid challenge.Device
We will correlate the changes in measuring cardiac output by both echocardiography and cardiometry with the changes in dynamic central venous oxygen saturation both at baseline and after fluid challenge to investigate the efficacy of dynamic central venous oxygen saturation in predicting fluid responsiveness in septic shock.
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring dynamic central venous oxygen saturation (ScvO2) at baseline and after fluid challenge.
Measured: After 30 mins
Secondary outcomes (1)
Measuring Cardiac output by echocardiography or cardiometry at baseline and after fluid challenge.
We will correlate the changes in measuring cardiac output by both echocardiography and cardiometry with the changes in dynamic central venous oxygen saturation both at baseline and after fluid challenge to investigate the efficacy of dynamic central venous oxygen saturation in predicting fluid responsiveness in septic shock.
Measured: After 30 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study startOct 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis and Septic ShockStudies of the same condition, open and under way.
- 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
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nevine Mostafa Soliman, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516236
- Sponsor's protocol ID
- 1/2026ANET30
- Status last verified
- Jan 2026
- First submitted
- 29 Mar 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Dynamic Central Venous Oxygen Saturation in Predicting Fluid Responsiveness in Septic Shock: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07516236
- Acronym / sponsor ID
- 1/2026ANET30
- Conditions
- Sepsis and Septic Shock
- Keywords
- Diagnostic Accuracy, Dynamic Venous Oxygen Saturation, Fluid Responsiveness, Septic Shock
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 7 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.
This prospective observational diagnostic accuracy study investigates the efficacy of dynamic central venous oxygen saturation in predicting fluid responsiveness in septic shock, compared to measurements obtained using echocardiography (VTI) and cardiometry. We will correlate the changes in measuring cardiac output by both echocardiography and cardiometry with the changes in dynamic central venous oxygen saturation both at baseline and after fluid challenge to investigate the efficacy of dynamic central venous oxygen saturation in predicting fluid responsiveness in septic shock.
Detailed description
All patients will undergo standardized monitoring to ensure accurate and reproducible hemodynamic assessment throughout the study period.
Blood pressure will be monitored noninvasively using an automated oscillometric cuff applied to the upper arm. MAP will be maintained at ≥65 mmHg with vasopressor support as required, and no changes in vasopressor infusion will be permitted during the measurement period.
A central venous catheter will be inserted in the internal jugular or subclavian vein, with the position confirmed by chest radiography. Central venous blood samples will be collected at baseline and after the fluid challenge for the determination of a Central venous oxygen saturation (ScvO₂).
Echocardiographic Assessment Left ventricular outflow tract (LVOT) diameter will be measured in the parasternal long-axis view by transthoracic echocardiography (Sonoscape S8 Echocardiography), and Doppler assessment of velocity- time integral (VTI) will be obtained in the apical five-chamber view. Stroke volume (SV) will be calculated as LVOT area × VTI, and values will be averaged from three consecutive cardiac cycles over a single respiratory cycle. The echocardiography operator will be an expert intensivist in echo operation (more than 7 years of experience), and the operator will be blinded to ScvO2.
Cardiac Output Monitoring (Electrical Cardiometry) Cardiac output will also be assessed noninvasively using a validated electrical cardiometry device (ICON®, Osypka Medical, Germany).
Parameters including stroke volume, cardiac output, and cardiac index will be documented at baseline and after the fluid challenge. Device calibration will be verified before each study session.
Timing of Measurements
Hemodynamic variables and oxygenation parameters will be recorded at two prespecified time points:
- Baseline - immediately prior to fluid challenge or passive leg raising maneuver.
- Post-intervention - within 5 minutes following intervention. Intervention A standardized fluid challenge protocol will be employed. Indications for fluid administration will include: Hypotension, defined as systolic blood pressure (SBP) ≤ 90 mmHg, a reduction in SBP ≥ 40 mmHg in patients with pre-existing hypertension, or mean arterial pressure (MAP) ≤ 65 mmHg, or evidence of tissue hypoperfusion, such as delayed capillary refill time, skin mottling, altered mental status, urine output ≤ 0.5 mL/kg/h for > 2 hours, or hyperlactatemia (> 2 mmol/L).
Eligible patients will receive a rapid infusion of 500 mL isotonic crystalloid solution ( normal saline) administered over a 15-minute period.
Throughout the intervention, all concomitant therapies-including background maintenance fluids, vasopressor or inotrope dosage, and mechanical ventilation settings-will remain unchanged to avoid confounding effects on hemodynamic measurements.
Definition of Fluid Responsiveness Fluid responsiveness will be defined as an increase in stroke volume index (derived from echocardiography or cardiometry) of ≥10- 15% after the intervention. This definition is consistent with established hemodynamic criteria and will serve as the reference standard for comparison with dynamic changes in ScvO₂. Stroke Volume Index (SVI) is the volume of blood pumped by the heart's ventricle with each beat, normalized to the individual's body surface area (BSA).
Data Collection For each patient, the following variables were systematically recorded: Baseline characteristics
- Demographic data (age, sex), and Comorbidities
- Source of infection
- Severity of illness scores:
- Acute Physiology and Chronic Health Evaluation II (APACHE II) o Sequential Organ Failure Assessment (SOFA)
- Life-support therapies as vasopressor use.
- Clinical outcomes (ICU length of stay, mortality) Hemodynamic and laboratory parameters Measured at two time points: immediately before the fluid challenge and within five minutes after completion.
- Heart rate (beats/min)
- Blood pressure
- Hemoglobin concentration (Hb, g/dL)
- Cardiac output (CO) by echocsardiography and electrical cardiometry
- Central venous blood gas analysis: Central venous oxygen saturation (ScvO₂)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This single-center, prospective, observational study will be conducted in the Intensive Care Unit (ICU) at Menoufia University Hospitals. Adults spontaneously breathing patients with septic shock who undergo a fluid challenge as a part of their hemodynamic management in the first 24 hours will be eligible for enrollment. Ethical approval will be obtained from the ethics committee at the Menoufia Faculty of Medicine, and the study will follow ethical guidelines and secure approval from the Institutional Review Board (IRB). Written informed consent will be obtained from each participant or their legal surrogate before study inclusion.
Key inclusion criteria (3 listed)
- Age > 18 years
- Diagnosis of septic shock according to Sepsis-3 criteria:
- Suspected or confirmed infection o Requirement for vasopressors to maintain MAP > 65 mmHg o Serum lactate > 2 mmol/L despite adequate fluid resuscitation
Key exclusion criteria (5 listed)
- Pregnancy
- Significant valvular heart disease.
- Atrial fibrillation.
- Inadequate echocardiographic window.
- Ongoing bleeding or contraindication to fluid bolus.
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 |
|---|---|---|
| Measuring dynamic central venous oxygen saturation (ScvO2) at baseline and after fluid challenge. Measuring Cardiac output by echocardiography or cardiometry at baseline and after fluid challenge.We will correlate the changes in measuring cardiac output by both echocardiography and cardiometry with the changes in dynamic central venous oxygen saturation both at baseline and after fluid challenge to investigate the efficacy of dynamic central venous oxygen saturation in predicting fluid responsiveness in septic shock. | Device | – |
Primary outcome
Measuring dynamic central venous oxygen saturation (ScvO2) at baseline and after fluid challenge.
Time frame: After 30 mins
1 secondary outcome
Measuring Cardiac output by echocardiography or cardiometry at baseline and after fluid challenge.
Time frame: After 30 mins
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 6 Oct 2026.
- Individual participant dataSharing planned: No
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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 and Septic Shock, run by Menoufia 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 3 inclusion and 5 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 6 Oct 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring dynamic central venous oxygen saturation (ScvO2) at baseline and after fluid challenge. (time frame: After 30 mins). 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 6 Oct 2026.