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

NCT06353659 | Not Yet Recruiting

• 1 other identifier: M2024077
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Intensive Care Unit; Acute Kidney Injury; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Acute kidney injury (according to KDIGO 2012 criteria)

  Acute kidney injury occur or not

  Through study completion, an average of 7 days

Study Arms (2)

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 without AKI

Patient diagnosed without AKI according to kidney disease improving global outcomes (KDIGO) 2012 criteria

Diagnostic Test: Contrast-enhanced Ultrasound

Interventions

Contrast-enhanced Ultrasound DIAGNOSTIC_TEST

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 with acute kidney injury (AKI); Patients without AKI

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

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.

You may qualify if:

• 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

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
• The quality of CEUS images is poor, and quantitative analysis cannot be performed

Sponsors & Collaborators

• Peking University Third Hospital: lead

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 5, 2024
• First Posted: April 9, 2024
• Study Start: April 15, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share