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NCT Number: NCT07550400

Role of Echocardiography and Ultrasound Indices in Resuscitation of Septic Shock Patients

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this 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.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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ▪ 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.
  • 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.

Exclusion criteria

  • ▪ 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

Treatment and study plan

carotid artery duplex

Procedure

, 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 area

Procedure
  • 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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

baheya kamel

CONTACT

[email protected]

+2-01115746487

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2026
Registry last updated
Apr 24, 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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