Clinical Application of Quantitative Ultrasonographic Analysis in Early Kidney Injury

Sponsor

Second Affiliated Hospital of Soochow University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05662774

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study was to quantify overall blood flow and renal cortical perfusion in patients with septic acute kidney injury (AKI) using ultrasound (US) Doppler and contrast-enhanced ultrasound (CEUS).

Condition or Disease	Intervention/Treatment	Phase
Patient Admitted to Hospital With Acute Kidney Injury Due to Sepsis	Diagnostic Test: Ultrasound contrast agent (Sonovue)

Detailed Description

Kidney ultrasound is the most widely used imaging modality in initial AKI workup as it is widely available and free of complications. It is clinically feasible to use US Doppler and contrast-enhanced US (CEUS) to detect macroscopic and microscopic changes in renal blood flow, and also cardiac output alterations.The aim was to analyze changes in US Doppler and CEUS quantitative parameters in patients with septic AKI to explore perfusion within the renal parenchyma, and also measure global renal blood flow and cardiac output.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

The Clinical Application of Ultrasound for Acute Kidney Injury During Sepsis - From Macroscopic to Microscopic Renal Perfusion Perspectives

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Nov 30, 2024

Anticipated Study Completion Date :

Nov 30, 2024

Outcome Measures

Primary Outcome Measures

Ultrasound Doppler parameters [First 24 hours after admission]
Time-averaged velocity (TAV)in cm/s
Ultrasound Doppler parameters [First 24 hours after admission]
Relative blood flow（RBF）in L/min
Ultrasonography parameters [First 24 hours after admission]
Time to peak (TTP)in senconds
Ultrasonography parameters [First 24 hours after admission]
Maximum intensity (Imax)in a.u（Acoustic intensity units）
Ultrasonography parameters [First 24 hours after admission]
area under curve is the multiplication of acoustic intensity and time（a.u*s）

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Meets the AKI diagnostic criteria of the Kidney Disease: Improving Global Outcomes (KDIGO)
Meets Sepsis 3.0 diagnostic criteria for sepsis: infection + SOFA ≥ 2

Exclusion Criteria:

Urinary tract obstruction, hydronephrosis, etc.
Left ventricular ejection fraction <30% (measured by transthoracic echocardiography), systolic pulmonary artery pressure >90 mmHg (measured by transthoracic echocardiography)
Allergy or adverse reaction to contrast media