Carotid Ultrasounds Measurements in Septic Shock

NCT ID: NCT05444621

Last Updated: 2022-07-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2024-10-31

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.

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).

Conditions

Septic Shock

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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 (ΔVpeak). The patient will be assessed pre- and post- passive leg raising (PLR) and after fluid challenge of 30 mL/Kg of IV crystalloid

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Abdelhameed Mohammed Hassan

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mohammed AM Hassan

Role: CONTACT

mohammedelahmer88@gmail.com

+2/01010706790

Ahmed MA Obaidullah, asst. prof

Role: CONTACT

ahmed.ali13@med.au.edu.eg

+2/01007556396

Related Links

https://link.springer.com/article/10.1007/s00134-021-06506-y?fbclid=IwAR022PGaW_CAvqLEy7QL3sW_JTa_QqG0cEjeWHljJrVqm_aGf18BkCfs9F4

Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021.

https://ccforum.biomedcentral.com/articles/10.1186/cc13891

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:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7991757/

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:

Other Identifiers

carotid US

Identifier Type: -

Identifier Source: org_study_id