Intensive Care UnitNCT06341062
The Application 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 at 1 site in China.
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… 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?
- Renal microcirculation quantitatively assessed by Contrast-enhanced ultrasound
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: 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.
Who may be able to join
- 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).
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;
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Ultrasound Diagnosis, Peking University Third Hospital
Beijing, Beijing Municipality
Ligang Cui, 13910627163, cuijuegang@126.com
About this study
Official title: The Application of Contrast-enhanced Ultrasound in Acute Kidney Injury in Intensive Care Unit
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:
- 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 renal microflow changes quantitatively evaluated by contrast-enhanced ultrasound in predicting renal function recovery.
Read the detailed description
Quantitative analysis of cortical perfusion by contrast-enhanced ultrasound； Echocardiography； Quantitative results of renal artery and vein spectrum
- Conditions
- Intensive Care Unit, Acute Kidney Injury, Ultrasound
- Being tested
- Renal microcirculation quantitatively assessed by 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.
Renal microcirculation quantitatively assessed by Contrast-enhanced ultrasoundOther
Renal microcirculation quantitatively assessed by Contrast-enhanced ultrasound before hospital discharge
| Study group | Role | What they receive |
|---|---|---|
| Patients recovering before hospital discharge | Recovery is defined as a return to normal serum creatinine and urine volume or more than 50% improvement in serum creatinine and/or urine volume from baseline | |
| Patients not recovering before hospital discharge | Non-recovery is defined as no significant improvement or further increase in serum creatinine and/or urine volume, the need for dialysis, or death. Receives: Other: Renal microcirculation quantitatively assessed by Contrast-enhanced ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
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 posted2 Apr 2024
- Study start15 Apr 2024
- 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
- 44 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
- NCT06341062
- Sponsor's protocol ID
- M2024078
- Status last verified
- Feb 2025
- First submitted
- 17 Mar 2024
- Last updated
- 17 Feb 2025
- 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 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Contrast-enhanced Ultrasound in Acute Kidney Injury in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06341062
- Acronym / sponsor ID
- M2024078
- Conditions
- Intensive Care Unit, Acute Kidney Injury, Ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 2 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 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:
- 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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients recovering before hospital discharge | – | –Recovery is defined as a return to normal serum creatinine and urine volume or more than 50% improvement in serum creatinine and/or urine volume from baseline |
| Patients not recovering before hospital discharge | – | Other: Renal microcirculation quantitatively assessed by Contrast-enhanced ultrasoundNon-recovery is defined as no significant improvement or further increase in serum creatinine and/or urine volume, the need for dialysis, or death. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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).
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 |
|---|---|---|
| Renal microcirculation quantitatively assessed by Contrast-enhanced ultrasoundRenal microcirculation quantitatively assessed by Contrast-enhanced ultrasound before hospital discharge | Other | Patients not recovering before hospital discharge |
Primary outcome
Serum creatinine values and/or urine output
Time frame: 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.)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- 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.
Ligang Cui, Dr principal investigator
Department of Ultrasound, Peking University Third Hospital
1 site in 1 country: see every site and its status.
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 at 1 site in China.
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: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Serum creatinine values and/or urine output (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 17 Feb 2025.