Carotid Ultrasounds Measurements in Septic Shock

NCT05444621 | Unknown

• 1 other identifier: carotid US
• Study Type: observational
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to assess carotid ultrasounds measurements, namely corrected flow time (FTc), velocity time integral (VTI) and respirophasic variation in carotid artery blood flow peak velocity (ΔVpeak), as a predictor of fluid responsiveness in septic shock patients.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• carotid usltrasounds and doppler measurements as predictor of fluid responsiveness in septic patient

  Assess carotid artery blood flow assessed by Ultrasounds as a predictor of fluid responsiveness in septic shock patients, and compare this measurements to standard one as echocardiography measurements of stroke volume and cardiac output (COP)to establish more easier method for assessment not depend of echo-window of patient and doesn't need expert one to do.

  baseline

Interventions

Ultrasound and doppler RADIATION

All patients are then assessed by transthoracic echocardiography to measure Left ventricle and Right ventricle function and to assess LVOT-VTI and SV. Doppler Ultrasound assessment of carotid arteries to assess corrected flow time (FTc), velocity time integral (VTI) and respirophasic variation in carotid artery blood flow peak velocity (ΔVpeak). The patient will be assessed pre- and post- passive leg raising (PLR) and after fluid challenge of 30 mL/Kg of IV crystalloid

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All recruited patients aged between 18 and 75 year old suspected to have septsis and septic shock are to be assessed at time of admission by history taking, thorough physical examination, laboratory workup. ECG, haemodynamic parameters and abdominal ultrasound including inferior vena cava (IVC) dimeter and collapsibility. Sequential Organ failure Assessment (SOFA) and Acute Physiology and Chronic Health Evaluation (APACHE-II) score to diagnose septic shock and eligibility to enter the study .

You may qualify if:

• Adult patients (18-75 year old) diagnosed with septic shock (MAP \>65mmHg), within 6 hours of admission or development of septic shock if previously admitted with other diagnoses.

You may not qualify if:

• patients have any of these conditions: Carotid artery stenosis ≥50%, known heart failure (Ejection fraction ≤45%) or End Stage Kidney Disease requiring haemodialysis.

Sponsors & Collaborators

• Assiut University: lead

Related Links

• Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021.
• Wu Y, Zhou S, Zhou Z, Liu B. A 10-second fluid challenge guided by transthoracic echocardiography can predict fluid responsiveness. Crit Care. 2014;;18::R108.. doi: 10.1186/cc13891. DOI:
• Sidor M, Premachandra L, Hanna B, Nair N, Misra A. Carotid flow as a surrogate for cardiac output measurement in Hemodynamically stable participants. J Intensive Care Med. 2020;;35::650--655.. doi: 10.1177/0885066618775694. DOI:

MeSH Terms

Conditions

Shock, Septic

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Central Study Contacts

Mohammed AM Hassan

CONTACT

+2/01010706790; mohammedelahmer88@gmail.com

Ahmed MA Obaidullah, asst. prof

CONTACT

+2/01007556396; ahmed.ali13@med.au.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: July 6, 2022
• Study Start: July 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: October 31, 2024
• Last Updated: July 6, 2022

Record last verified: 2022-07