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

NCT06341062 | Recruiting

• 1 other identifier: M2024078
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.To explore the quantitative parameters of contrast-enhanced ultrasound which can reflect the changes of renal microcirculation.
2. 2.To explore the relationship between renal microcirculation and systemic hemodynamics.
3. 3.To explore the value of renal microflow changes quantitatively evaluated by contrast-enhanced ultrasound in predicting renal function recovery.

Conditions

Intensive Care Unit; Acute Kidney Injury; Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Interventions

Renal microcirculation quantitatively assessed by Contrast-enhanced ultrasound OTHER

Renal microcirculation quantitatively assessed by Contrast-enhanced ultrasound before hospital discharge

Patients not recovering before hospital discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Department of Ultrasound Diagnosis, Peking University Third Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Ligang Cui, Dr

  Department of Ultrasound, Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuewei Zhang, Dr

CONTACT

18800109082; zhang_yue_wei@126.com

Ligang Cui, Dr

CONTACT

13910627163; cuiligang_bysy@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: April 2, 2024
• Study Start: April 15, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)