NCT07550400

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
6mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
May 2026Nov 2026

First Submitted

Initial submission to the registry

April 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 24, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

May 3, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2026

Expected
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2026

Last Updated

April 24, 2026

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

April 18, 2026

Last Update Submit

April 18, 2026

Conditions

Keywords

End diastolic diametercarotid artery duplexseptic shock

Outcome Measures

Primary Outcomes (1)

  • Accuracy of echo and ultrasound indices

    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.

    1 Day

Study Arms (1)

septic shock patients

septic shock according to SOFA score more than or equal 1

Procedure: carotid artery duplexProcedure: Left ventricular end diastolic area

Interventions

, 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

septic shock patients

* 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

septic shock patients

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

septic shock patients in ICU

You may qualify if:

  • ▪ 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.

You may not qualify if:

  • ▪ 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Ain Shams University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2026

First Posted

April 24, 2026

Study Start

May 3, 2026

Primary Completion (Estimated)

November 2, 2026

Study Completion (Estimated)

November 12, 2026

Last Updated

April 24, 2026

Record last verified: 2025-09

Locations