Patient Admitted to Hospital With Acute Kidney Injury Due to SepsisNCT05662774
Clinical Application of Quantitative Ultrasonographic Analysis in Early Kidney Injury
An observational study of Patient Admitted to Hospital With Acute Kidney Injury Due to Sepsis, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
The purpose of this study was to quantify overall blood flow and renal cortical perfusion in patients with septic acute kidney injury (AKI) using ultrasound (US) Doppler and contrast-enhanced ultrasound (CEUS). Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Patient Admitted to Hospital With Acute Kidney Injury Due to Sepsis
- What is being tested?
- Ultrasound contrast agent (Sonovue)
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 30 Nov 2024
- 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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to the Intensive Care Unit who meet the above inclusion criteria
Who may be able to join
- Meets the AKI diagnostic criteria of the Kidney Disease: Improving Global Outcomes (KDIGO)
- Meets Sepsis 3.0 diagnostic criteria for sepsis: infection + SOFA ≥ 2
Who cannot join
- Urinary tract obstruction, hydronephrosis, etc.
- Left ventricular ejection fraction <30% (measured by transthoracic echocardiography), systolic pulmonary artery pressure >90 mmHg (measured by transthoracic echocardiography)
- Allergy or adverse reaction to contrast media
Trial locations and contacts
1 site in 1 country.
Yunzhu YU contact
China1 site, 1 recruiting
- Recruiting
The Second Hospital of Soochow University
Suzhou, Jiangsu, 215004
Peiqing Liu, +8618625268629, liupeiqing8877@163.com
About this study
Official title: The Clinical Application of Ultrasound for Acute Kidney Injury During Sepsis - From Macroscopic to Microscopic Renal Perfusion Perspectives
The purpose of this study was to quantify overall blood flow and renal cortical perfusion in patients with septic acute kidney injury (AKI) using ultrasound (US) Doppler and contrast-enhanced ultrasound (CEUS).
Read the detailed description
Kidney ultrasound is the most widely used imaging modality in initial AKI workup as it is widely available and free of complications. It is clinically feasible to use US Doppler and contrast-enhanced US (CEUS) to detect macroscopic and microscopic changes in renal blood flow, and also cardiac output alterations.The aim was to analyze changes in US Doppler and CEUS quantitative parameters in patients with septic AKI to explore perfusion within the renal parenchyma, and also measure global renal blood flow and cardiac output.
- Being tested
- Ultrasound contrast agent (Sonovue)
- Keywords
- Acute kidney injury, contrast-enhanced ultrasound, renal perfusion, microcirculation
- 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.
Ultrasound contrast agent (Sonovue)Diagnostic test
Patients are diagnosed by intravenous injection of ultrasound contrast on the first day of admission and information is collected by diagnostic ultrasound instruments
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound Doppler parameters
Time-averaged velocity (TAV)in cm/s
Measured: First 24 hours after admission
Ultrasound Doppler parameters
Relative blood flow（RBF）in L/min
Measured: First 24 hours after admission
Ultrasonography parameters
Time to peak (TTP)in senconds
Measured: First 24 hours after admission
Ultrasonography parameters
Maximum intensity (Imax)in a.u（Acoustic intensity units）
Measured: First 24 hours after admission
Ultrasonography parameters
area under curve is the multiplication of acoustic intensity and time（a.u*s）
Measured: First 24 hours after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start1 Jan 2023 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Admitted to Hospital With Acute Kidney Injury Due to SepsisStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- The Second Hospital of Soochow University The Second Hospital of Soochow University, Study chair, The Second Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662774
- Sponsor's protocol ID
- JD-HG-2021-40
- Status last verified
- Dec 2022
- First submitted
- 28 Nov 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan to share data publicly after patent application or academic paper publication
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Application of Ultrasound for Acute Kidney Injury During Sepsis - From Macroscopic to Microscopic Renal Perfusion Perspectives
- ClinicalTrials.gov ID
- NCT05662774
- Acronym / sponsor ID
- JD-HG-2021-40
- Keywords
- Acute kidney injury, contrast-enhanced ultrasound, renal perfusion, microcirculation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 22 Dec 2022 (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 purpose of this study was to quantify overall blood flow and renal cortical perfusion in patients with septic acute kidney injury (AKI) using ultrasound (US) Doppler and contrast-enhanced ultrasound (CEUS).
Detailed description
Kidney ultrasound is the most widely used imaging modality in initial AKI workup as it is widely available and free of complications. It is clinically feasible to use US Doppler and contrast-enhanced US (CEUS) to detect macroscopic and microscopic changes in renal blood flow, and also cardiac output alterations.The aim was to analyze changes in US Doppler and CEUS quantitative parameters in patients with septic AKI to explore perfusion within the renal parenchyma, and also measure global renal blood flow and cardiac output.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the Intensive Care Unit who meet the above inclusion criteria
Key inclusion criteria (2 listed)
- Meets the AKI diagnostic criteria of the Kidney Disease: Improving Global Outcomes (KDIGO)
- Meets Sepsis 3.0 diagnostic criteria for sepsis: infection + SOFA ≥ 2
Key exclusion criteria (3 listed)
- Urinary tract obstruction, hydronephrosis, etc.
- Left ventricular ejection fraction <30% (measured by transthoracic echocardiography), systolic pulmonary artery pressure >90 mmHg (measured by transthoracic echocardiography)
- Allergy or adverse reaction to contrast media
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 |
|---|---|---|
| Ultrasound contrast agent (Sonovue)Patients are diagnosed by intravenous injection of ultrasound contrast on the first day of admission and information is collected by diagnostic ultrasound instruments | Diagnostic test | – |
Primary outcome
Ultrasound Doppler parameters
Time frame: First 24 hours after admission
Time-averaged velocity (TAV)in cm/s
Ultrasound Doppler parameters
Time frame: First 24 hours after admission
Relative blood flow（RBF）in L/min
Ultrasonography parameters
Time frame: First 24 hours after admission
Time to peak (TTP)in senconds
Ultrasonography parameters
Time frame: First 24 hours after admission
Maximum intensity (Imax)in a.u（Acoustic intensity units）
Ultrasonography parameters
Time frame: First 24 hours after admission
area under curve is the multiplication of acoustic intensity and time（a.u*s）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Individual participant dataSharing planned: No. Plan to share data publicly after patent application or academic paper publication
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.
Yunzhu YU contact
The Second Hospital of Soochow University The Second Hospital of Soochow University study chair
The Second Hospital of Soochow University
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 Patient Admitted to Hospital With Acute Kidney Injury Due to Sepsis, run by Second Affiliated Hospital of Soochow University 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 2 inclusion and 3 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 22 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peiqing Liu (+8618625268629, liupeiqing8877@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound Doppler parameters (time frame: First 24 hours after admission). The study lists 5 primary outcomes in all. 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 22 Dec 2022.