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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06341062
• Other study ID #: M2024078
• Status: Not yet recruiting
• Start date: April 15, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: Peking University Third Hospital
• Contact: Yuewei Zhang, Dr
• Phone: 18800109082
• Email: zhang_yue_wei[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Acute Kidney Injury
• Intensive Care Unit
• Ultrasound
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
China	Department of Ultrasound Diagnosis, Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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