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NCT Number: NCT07516236

Dynamic SvO2 in Predicting Fluid Responsiveness in Septic Shock

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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:

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Pregnancy
  • Significant valvular heart disease.
  • Atrial fibrillation.
  • Inadequate echocardiographic window.
  • Ongoing bleeding or contraindication to fluid bolus.

Treatment and study plan

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.

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.

    Time frame: After 30 mins

    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.

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Diagnostic Accuracy of Dynamic Central Venous Oxygen Saturation in Predicting Fluid Responsiveness in Septic Shock: A Prospective Observational Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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