The Application of Contrast-enhanced Ultrasound in Acute Kidney Injury in ICU

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

The goal of this study is to quantitatively assess renal microcirculation changes by contrast-enhanced ultrasound 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 its predictive value in renal function recovery in patients with critical acute kidney injury. 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 renal microflow changes quantitatively evaluated by contrast-enhanced ultrasound in predicting renal function recovery.

Study Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury; Intensive Care Unit; Ultrasound
• Intervention / Treatment: Other: Renal microcirculation quantitatively assessed by Contrast-enhanced ultrasound

Detailed Description

Quantitative analysis of cortical perfusion by contrast-enhanced ultrasound； Echocardiography； Quantitative results of renal artery and vein spectrum

• Study Type: Observational
• Enrollment (Estimated): 44

Contacts and Locations

• Study Contact: Name: Yuewei Zhang, Dr; Phone Number: 18800109082; Email: zhang_yue_wei@126.com
• Study Contact Backup: Name: Ligang Cui, Dr; Phone Number: 13910627163; Email: cuiligang_bysy@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Department of Ultrasound Diagnosis, Peking University Third Hospital
      • Contact: Ligang Cui; Phone Number: 13910627163; Email: cuijuegang@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Published contrast-enhanced ultrasound data from critically ill patients are limited. Through literature review, the area under the curve of contrast-enhanced ultrasound to predict kidney recovery in critically ill AKI patients is 0.72, and the width of confidence interval is 0.35. When α=0.05, the sample size N=34 is obtained by using PASS software. Considering the 20% shedding rate, 44 patients are expected to be enrolled in this study.

Description

Inclusion Criteria:

• Age >18 years old;
• AKI was diagnosed < 24 hours after first admission to intensive care unit (ICU) and the expected length of stay in ICU ≥48 hours;
• Meet Kidney Disease Improving Global Outcomes (KDIGO) 2012 diagnostic criteria for acute kidney injury;
• Contrast-enhanced ultrasound was performed within 24 hours after diagnosis of acute kidney injury (AKI).

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;
• Allergy to contrast agent SonoVue(BraccoSpA, Milan, Italy) or its components, or the presence of severe cardiopulmonary insufficiency (e.g., right-to-left shunt heart disease or pulmonary systolic blood pressure >90mmHg).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients recovering before hospital discharge; Recovery is defined as a return to normal serum creatinine and urine volume or more than 50% improvement in serum creatinine and/or urine volume from baseline
Patients not recovering before hospital discharge; Non-recovery is defined as no significant improvement or further increase in serum creatinine and/or urine volume, the need for dialysis, or death.	Other: Renal microcirculation quantitatively assessed by Contrast-enhanced ultrasound; Renal microcirculation quantitatively assessed by Contrast-enhanced ultrasound before hospital discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum creatinine values and/or urine output	Complete recovery (defined as a return to normal serum creatinine and urine volume) and reversal of acute kidney injury (AKI) (more than 50% improvement in serum creatinine and/or urine volume from baseline), non-recovery included persistent AKI(no significant improvement or further increase in serum creatinine and/or urine volume, the need for dialysis, or death.)	Through study completion, an average of 7 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: March 17, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury; Wounds and Injuries
• Other Study ID Numbers: M2024078

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