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RecruitingNCT07516236Updated Oct 6, 2026

Dynamic SvO2 in Predicting Fluid Responsiveness in Septic Shock

An observational study in Sepsis and Septic Shock, sponsored by Menoufia University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.

Primary conditionShock, SepticRegistry: SepsisReclassifiedWhy we changed it
Registry
Sepsis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Shock, Septic
Why
  1. The study's listed conditions name Shock, Septic, a narrower term within Sepsis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Menoufia University · Observational

Updated Oct 6, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
115
Ages
18 Years and older
Sex
All
01

Study 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. 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:

  1. Baseline - immediately prior to fluid challenge or passive leg raising maneuver.
  2. 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:

    o 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)
02

Conditions studied

  • Sepsis and Septic Shock

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Keywords

  • Diagnostic Accuracy
  • Dynamic Venous Oxygen Saturation
  • Fluid Responsiveness
  • Septic Shock
03

In context

Shock, Septic Reclassified

1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.

This study's planned enrollment of 115 is close to the median of 108 across 406 observational studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

Menoufia University is the lead sponsor of 199 studies on the registry; 54 are open to participants now.

Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Significant valvular heart disease.
  • Atrial fibrillation.
  • Inadequate echocardiographic window.
  • Ongoing bleeding or to fluid bolus.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
115 participants (estimated)
Patient registry
No

Interventions

  • DeviceMeasuring 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.

06

What researchers measure

Primary outcomes

  1. Measuring dynamic central venous oxygen saturation (ScvO2) at baseline and after fluid challenge.

    Time frame: 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.

    Time frame: After 30 mins

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Jan 2027, 3 months later.

Of 189 non-industry observational studies under Shock, Septic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 47. This study's planned 3 months is below that.

Counting every sponsor, half of 202 studies reached it within 25 months; a quarter within 12 and three quarters within 47.

Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Oct 2026, on Oct 6, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Mar 29, 2026
First posted
Apr 7, 2026
StartEst.
Oct 2026was Aug 2026
Primary completionEst.
Jan 2027
CompletionEst.
Feb 2027
Last update
Oct 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 6, 2026
Sites
Menoufia University is now Recruiting
Oct 6, 2026
Start date
Aug 1, 2026→Oct 2026
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Not yet recruiting→Recruiting
    Menoufia University is now Recruiting
    Start date Aug 1, 2026→Oct 2026

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07516236
Responsible party
Nevine Mostafa Soliman (Assistant Professor, Menoufia University) — Principal investigator
First posted
Apr 7, 2026
Start date
Oct 2026 (estimated)
Primary completion
Jan 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Oct 6, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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