Carotid Ultrasounds Measurements in Septic Shock

Carotid Ultrasounds Measurements for Assessment of Fluid Responsiveness in Septic Shock

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Septic Shock
• Intervention / Treatment: Radiation: Ultrasound and doppler

Detailed Description

Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection . Early identification and appropriate management in the initial hours after the development of sepsis improve outcomes.

For patients with sepsis-induced hypoperfusion or septic shock it is recommended to give IV crystalloid fluid within the first 3 hr of resuscitation . However, fluid responsiveness varies widely between cases. Determining the optimal amount of fluid to be administered remains a critical issue in clinical practice and research. Recent studies have shown that not every patient advantages from intravenous hydration, only 40% of hypotensive patients with sepsis benefit, and the others who do not respond are liable to develop pulmonary edema with high associated mortality . Studies have shown that aortic blood peak velocity had high sensitivity and specificity to predict fluid responsiveness, however, measurements of aortic blood flow velocity need a transesophageal ultrasound which is an invasive procedure . Measurement of left ventricular outflow tract velocity time integral (LVOTVTI), derived stroke volume (SV), and cardiac output reliably predicts fluid responsiveness in critically ill patients but it is difficult and dependent on operator and echo windows . There is a need to find a non-invasive accurate and easy method to assess fluid responsiveness in septic shock patients. Different Measurements of carotid artery flow have been suggested recently to predict fluid responsiveness. A promising measurements are corrected flow time (FTc), velocity time integral (VTI) and respirophasic variation in carotid artery blood flow peak velocity (ΔVpeak).

• Study Type: Observational
• Enrollment (Anticipated): 72

Contacts and Locations

• Study Contact: Name: Mohammed AM Hassan; Phone Number: +2/01010706790; Email: mohammedelahmer88@gmail.com
• Study Contact Backup: Name: Ahmed MA Obaidullah, asst. prof; Phone Number: +2/01007556396; Email: ahmed.ali13@med.au.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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 .

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

Helpful Links

• Singer M, Deutschman CS, Seymour CW, et al: The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA 2016; 315:801-810.
• Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021.
• Mallat J, Meddour M, Durville E, Lemyze M, Pepy F, Temime J, et al. Decrease in pulse pressure and stroke volume variations after mini-fluid challenge accurately predicts fluid responsiveness. Br J Anaesth. 2015;115(3):449-56.
• 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:

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): October 31, 2024

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: July 2, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 2, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: carotid US

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No