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

Not yet recruiting

• Conditions: Intensive Care Unit; Acute Kidney Injury; Ultrasound
• Interventions: Other: Renal microcirculation quantitatively assessed by Contrast-enhanced ultrasound

• Registration Number: NCT06341062
• Lead Sponsor: Peking University Third Hospital

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. 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2024-03-17
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-01
• Last Update Submitted: 2024-04-01
• Study First Posted: 2024-04-02
• Last Update Posted: 2024-04-02
• Study Start: 2024-04-15
• Primary Completion: 2025-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

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).

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients not recovering before hospital discharge	Renal microcirculation quantitatively assessed by Contrast-enhanced ultrasound	Non-recovery is defined as no significant improvement or further increase in serum creatinine and/or urine volume, the need for dialysis, or death.

Primary Outcome Measures

Name	Time	Method
Serum creatinine values and/or urine output	Through study completion, an average of 7 days	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.)

Trial Locations

Locations (1)

Department of Ultrasound Diagnosis, Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China