The Application of Contrast-enhanced Ultrasound in Acute Kidney Injury in ICU
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeking University Third Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Known severe chronic kidney disease (CKD≥ stage 4) or undergoing hemodialysis treatment;
Kidney transplantation or renal malignancy;
Terminal stage of malignant tumor;
Pregnancy;
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Renal microcirculation quantitatively assessed by Contrast-enhanced ultrasound
Other interventionRenal microcirculation quantitatively assessed by Contrast-enhanced ultrasound before hospital discharge
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Patients recovering before hospital discharge0 interventions
Group B: Patients not recovering before hospital discharge1 intervention
Trial outcomes
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.)
Time frame
Through study completion, an average of 7 daysSponsors and contacts
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Source ClinicalTrials.gov