Acute Kidney InjuryNCT02347930
Establish and Apply the Evaluation System of Ultrasonic Integrated Technology for Prevention and Treatment of Acute Kidney Injury
An observational study of Acute Kidney Injury, run by RenJi Hospital at 1 site in China.
Trial summary
Establish an integrated evaluation system of ultrasound technology for the prognosis of acute kidney injury, and in order to achieve non-invasive, reliable early diagnosis "gold standard". Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- kidney ultrasound
- How many people
- 196 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to 30 Dec 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Confirmed acute kidney injury
Who may be able to join
- Subjects must satisfy the following criteria to be enrolled in the study:
- Clinical diagnosis of acute or chronic kidney injury
- Male or female, aged 18-80 years old
- signed informed consent
- Patients can breathe in, breathe out and hold their breathe with ease, communication without difficulty.
Who cannot join
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Refuse to sign informed consent
- allergy to micro bubble hexafluoride drug
- Patients with cardiopulmonary insufficiency, pleural effusion, pulmonary infections
- Patients with asthma, chronic bronchitis
- Patients with pregnancy
- Patients can't cooperate or have a difficulty in breathing in, breathing out or holding their breathe
- Patients beening diagnosed with End-stage kidney disease.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of nephrology , Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
About this study
Establish an integrated evaluation system of ultrasound technology for the prognosis of acute kidney injury, and in order to achieve non-invasive, reliable early diagnosis "gold standard". Set up collabration with the expert in National Cheng Kung University Medical Center of Taiwan who did a lot of excellent work in basic research of prevention the progression of acut kidney injury. Study the experience about prevention progression of kidney disease in clinical and basic field. Establish cooperation with the professional in Hong Kong University of Science and Technology. To set up the system of natural products research and assess the Astragalus medicinal value.
- Conditions
- Acute Kidney Injury
- Being tested
- kidney ultrasound
- Keywords
- acute kidney injury, ultrasound technology
- 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.
kidney ultrasoundOther
kidney ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Confirmed acute kidney injury | Confirmed acute kidney injury Receives: Other: kidney ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the results of kidney ultrasound with biomarkers of acute kidney injury
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startApr 2014
- Primary completion15 Nov 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Other
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- shan mou, Dr., Principal investigator, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347930
- Sponsor's protocol ID
- 2014DFT30090
- Status last verified
- Nov 2023
- First submitted
- 22 Jan 2015
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establish and Apply the Evaluation System of Ultrasonic Integrated Technology for Prevention and Treatment of Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT02347930
- Acronym / sponsor ID
- 2014DFT30090
- Conditions
- Acute Kidney Injury
- Keywords
- acute kidney injury, ultrasound technology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- China-Japan Friendship Hospital, National Cheng-Kung University Hospital
- Study start
- Apr 2014
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 28 Jan 2015 (estimated)
- 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.
Establish an integrated evaluation system of ultrasound technology for the prognosis of acute kidney injury, and in order to achieve non-invasive, reliable early diagnosis "gold standard". Set up collabration with the expert in National Cheng Kung University Medical Center of Taiwan who did a lot of excellent work in basic research of prevention the progression of acut kidney injury. Study the experience about prevention progression of kidney disease in clinical and basic field. Establish cooperation with the professional in Hong Kong University of Science and Technology. To set up the system of natural products research and assess the Astragalus medicinal value.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Confirmed acute kidney injury | – | Other: kidney ultrasoundConfirmed acute kidney injury |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Confirmed acute kidney injury
Key inclusion criteria (5 listed)
- Subjects must satisfy the following criteria to be enrolled in the study:
Key exclusion criteria (8 listed)
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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 |
|---|---|---|
| kidney ultrasoundkidney ultrasound | Other | Confirmed acute kidney injury |
Primary outcome
compare the results of kidney ultrasound with biomarkers of acute kidney injury
Time frame: up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
shan mou, Dr. principal investigator
Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
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 Acute Kidney Injury, run by RenJi 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 27 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare the results of kidney ultrasound with biomarkers of acute kidney injury (time frame: up to 24 months). 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 27 Nov 2023.