Intensive Care UnitNCT06353659
The Diagnostic Value of Contrast-enhanced Ultrasound in Acute Kidney Injury in ICU
An observational study of Intensive Care Unit and Acute Kidney Injury, run by Peking University Third Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit, Acute Kidney Injury, Ultrasound
- What is being tested?
- Contrast-enhanced Ultrasound
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Diagnostic Value of Contrast-enhanced Ultrasound in Acute Kidney Injury in Intensive Care Unit
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.
Read the detailed description
The main questions it aims to answer are:
- To explore the quantitative parameters of contrast-enhanced ultrasound which can reflect the changes of renal microcirculation。
- To explore the relationship between renal microcirculation and systemic hemodynamics。
- To explore the value of quantitative evaluation of renal microcirculation changes by contrast-enhanced ultrasound in the diagnosis of acute kidney injury
- Conditions
- Intensive Care Unit, Acute Kidney Injury, Ultrasound
- Being tested
- Contrast-enhanced Ultrasound
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-enhanced UltrasoundDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute kidney injury (AKI) | Patient diagnosed with AKI according to kidney disease improving global outcomes (KDIGO) 2012 criteria Receives: Diagnostic Test: Contrast-enhanced Ultrasound | |
| Patients without AKI | Patient diagnosed without AKI according to kidney disease improving global outcomes (KDIGO) 2012 criteria Receives: Diagnostic Test: Contrast-enhanced Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury (according to KDIGO 2012 criteria)
Acute kidney injury occur or not
Measured: Through study completion, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start15 Apr 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cui Ligang, Peking University Third Hospital
- Investigators
- Ligang Cui, Dr, Principal investigator, Department of Ultrasound, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353659
- Sponsor's protocol ID
- M2024077
- Status last verified
- Apr 2024
- First submitted
- 5 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Value of Contrast-enhanced Ultrasound in Acute Kidney Injury in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06353659
- Acronym / sponsor ID
- M2024077
- Conditions
- Intensive Care Unit, Acute Kidney Injury, Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 15 Apr 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The main questions it aims to answer are:
- To explore the quantitative parameters of contrast-enhanced ultrasound which can reflect the changes of renal microcirculation。
- To explore the relationship between renal microcirculation and systemic hemodynamics。
- To explore the value of quantitative evaluation of renal microcirculation changes by contrast-enhanced ultrasound in the diagnosis of acute kidney injury
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with acute kidney injury (AKI) | – | Diagnostic Test: Contrast-enhanced UltrasoundPatient diagnosed with AKI according to kidney disease improving global outcomes (KDIGO) 2012 criteria |
| Patients without AKI | – | Diagnostic Test: Contrast-enhanced UltrasoundPatient diagnosed without AKI according to kidney disease improving global outcomes (KDIGO) 2012 criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast-enhanced UltrasoundPatients with acute kidney injury high risk factors (KDIGO 2012) will undergo a contrast-enhanced ultrasound within 24 hours of admission to the ICU | Diagnostic test | Patients with acute kidney injury (AKI), Patients without AKI |
Primary outcome
Acute kidney injury (according to KDIGO 2012 criteria)
Time frame: Through study completion, an average of 7 days
Acute kidney injury occur or not
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ligang Cui, Dr principal investigator
Department of Ultrasound, Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit and Acute Kidney Injury, run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuewei Zhang, Dr (18800109082, zhang_yue_wei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute kidney injury (according to KDIGO 2012 criteria) (time frame: Through study completion, an average of 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.