The Diagnostic Value of Contrast-enhanced Ultrasound in Acute Kidney Injury in ICU

April 7, 2024 updated by: Cui Ligang, Peking University Third Hospital

The Diagnostic Value of Contrast-enhanced Ultrasound in Acute Kidney Injury in Intensive Care Unit

The goal of this observational study is to quantitatively assess the renal microcirculation changes by contrast-enhanced ultrasound (CEUS) and to obtain systemic hemodynamic information by ultrasound Doppler at the same time, to analyze the relationship between renal microcirculation changes and systemic hemodynamic changes, and to explore the diagnostic value of CEUS in critically ill acute kidney injury.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The main questions it aims to answer are:

  1. To explore the quantitative parameters of contrast-enhanced ultrasound which can reflect the changes of renal microcirculation。
  2. To explore the relationship between renal microcirculation and systemic hemodynamics。
  3. To explore the value of quantitative evaluation of renal microcirculation changes by contrast-enhanced ultrasound in the diagnosis of acute kidney injury

Study Type

Observational

Enrollment (Estimated)

60

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Through literature review, the latest meta-analysis results showed that the area under the curve of CEUS parameters for diagnosing AKI was 0.84 and the width of the confidence interval was 0.22. When α=0.05, the sample size N=54 was obtained by PASS software. Considering the 10% shedding rate, 60 patients were expected to be enrolled in this study.

Description

Inclusion Criteria:

  • Age>18 years old
  • First admission to ICU < 24h after admission and expected ICU stay ≥48 hours
  • Acute kidney injury risk factors (KDIGO 2012)
  • Contrast-enhanced ultrasound

Exclusion Criteria:

  • Known severe chronic kidney disease (CKD≥ stage 4) or undergoing hemodialysis treatment
  • Kidney transplantation or renal malignancy
  • Terminal stage of malignant tumor
  • Pregnancy
  • Renal artery stenosis or renal vein thrombosis
  • The quality of CEUS images is poor, and quantitative analysis cannot be performed

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with acute kidney injury (AKI)
Patient diagnosed with AKI according to kidney disease improving global outcomes (KDIGO) 2012 criteria
Diagnostic test: Contrast-enhanced Ultrasound
Patients with acute kidney injury high risk factors (KDIGO 2012) will undergo a contrast-enhanced ultrasound within 24 hours of admission to the ICU
Patients without AKI
Patient diagnosed without AKI according to kidney disease improving global outcomes (KDIGO) 2012 criteria
Diagnostic test: Contrast-enhanced Ultrasound
Patients with acute kidney injury high risk factors (KDIGO 2012) will undergo a contrast-enhanced ultrasound within 24 hours of admission to the ICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute kidney injury (according to KDIGO 2012 criteria)
Time Frame: Through study completion, an average of 7 days
Acute kidney injury occur or not
Through study completion, an average of 7 days

Collaborators and Investigators

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

Sponsor

Peking University Third Hospital

Investigators

  • Principal Investigator: Ligang Cui, Dr, Department of Ultrasound, Peking University Third Hospital

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 (Estimated)

April 15, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

March 5, 2024

First Submitted That Met QC Criteria

April 7, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 7, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2024077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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