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Recruiting NCT07550400

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

— Observational Septic Shock Fluid Resuscitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: carotid artery duplex, Left ventricular end diastolic area.
Who it may be relevant to
Registry conditions: Septic Shock, Fluid Resuscitation. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Detailed description

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.

Interventions

  • Procedure carotid artery duplex
    , 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 for
  • Procedure Left ventricular end diastolic area
    * 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 (30m

Primary outcome measures

  • Accuracy of echo and ultrasound indices [Time frame: 1 Day]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Faculty of medicine, Ain Shams University — Cairo

Identifiers

NCT: NCT07550400 · FMASU MD 240L2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗