Clinical Application of Quantitative Ultrasonographic Analysis in Early Kidney Injury

December 15, 2022 updated by: Second Affiliated Hospital of Soochow University

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Yunzhu YU
  • Phone Number: +8613382147113

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215004
        • Recruiting
        • The Second Hospital of Soochow University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients admitted to the Intensive Care Unit who meet the above inclusion criteria

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Soochow University

Investigators

  • Study Chair: The Second Hospital of Soochow University The Second Hospital of Soochow University, The Second Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

November 30, 2024

Study Completion (Anticipated)

November 30, 2024

Study Registration Dates

First Submitted

November 28, 2022

First Submitted That Met QC Criteria

December 15, 2022

First Posted (Estimate)

December 22, 2022

Study Record Updates

Last Update Posted (Estimate)

December 22, 2022

Last Update Submitted That Met QC Criteria

December 15, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JD-HG-2021-40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Plan to share data publicly after patent application or academic paper publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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