Carotid Ultrasounds Measurements in Septic Shock

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05444621
Collaborator
(none)
72
28

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
72 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Carotid Ultrasounds Measurements for Assessment of Fluid Responsiveness in Septic Shock
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Oct 31, 2024

Outcome Measures

Primary Outcome Measures

  1. carotid usltrasounds and doppler measurements as predictor of fluid responsiveness in septic patient [baseline]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Mohammed Abdelhameed Mohammed Hassan, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05444621
Other Study ID Numbers:
  • carotid US
First Posted:
Jul 6, 2022
Last Update Posted:
Jul 6, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 6, 2022