Carotid Ultrasounds Measurements in Septic Shock

Septic Shock Clinical Trial

Official title:

Carotid Ultrasounds Measurements for Assessment of Fluid Responsiveness in Septic Shock

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05444621
• Other study ID #: carotid US
• Status: Not yet recruiting
• Start date: July 1, 2022
• Est. completion date: October 31, 2024

Study information

• Verified date: July 2022
• Source: Assiut University
• Contact: Mohammed AM Hassan
• Phone: +2/01010706790
• Email: mohammedelahmer88[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: October 31, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Radiation:
• Ultrasound and doppler
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 (?Vpeak). The patient will be assessed pre- and post- passive leg raising (PLR) and after fluid challenge of 30 mL/Kg of IV crystalloid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   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.
•   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:
•   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.
•   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: