- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06156098
Bedside Renal Ultrasound Assessment in Patients With Acute Kidney Injury
April 8, 2024 updated by: Qin Zhang
Bedside Renal Ultrasound Assessment in Critically Ill Patients With Acute Kidney Injury: an Observational Study
Exploring the predictive and evaluative value of various indicators of bedside critical renal ultrasound in critically ill patients with acute kidney injury (AKI)
Study Overview
Detailed Description
This study aims to perform bedside renal ultrasound examinations on critically ill patients admitted to the ICU (including sepsis, respiratory failure, shock, multiple trauma, etc.) and prospectively observe the relationship between ultrasound parameters and the occurrence and progression of AKI, in conjunction with traditional renal function indicators.
This will provide clinicians with a rapid, non-invasive, and visual examination tool at the bedside for early diagnosis and treatment of AKI.
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Qin Zhang, phd
- Phone Number: 15717154768
- Email: qzhang8@tjh.tjmu.edu.cn
Study Contact Backup
- Name: Xiao Zhang, phd
- Phone Number: 15926207366
- Email: ranxiao1001@tjh.tjmu.edu.cn
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430030
- Recruiting
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
Contact:
- Qin Zhang, phd
- Phone Number: 15717154768
- Email: qzhang8@tjh.tjmu.edu.cn
-
Contact:
- Xiao Ran, phd
- Phone Number: 15926207366
- Email: ranxiao1001@tjh.tjmu.edu.cn
-
Principal Investigator:
- Qin Zhang, phd
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
Criteria for sepsis patients: Clear infection focus, Sequential Organ Failure Assessment (SOFA) score ≥ 2. Criteria for septic shock patients: Despite active fluid resuscitation, patients still require vasoactive drugs to maintain blood pressure, with arterial blood lactate level ≥ 2mmol/L.
Other critically ill patients include those with shock of various causes,
Description
Inclusion Criteria:
- Age ≥ 18 years and ≤ 70 years
- Criteria for sepsis patients
Exclusion Criteria:
- Pregnant women.
- Patients with malignant tumors, severe heart failure, chronic renal insufficiency, end stage renal disease, kidney transplantation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival
Time Frame: 28 days
|
28-day mortality rate
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AKI
Time Frame: 28 days
|
duration of continuous renal replacement therapy (CRRT)during hospitalization, length of hospital stay, duration of ICU stay, hospital mortality rate, 28-day mortality rate, and other relevant data.
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Qin Zhang, phd, Tongji Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2023
Primary Completion (Actual)
November 30, 2023
Study Completion (Estimated)
September 30, 2024
Study Registration Dates
First Submitted
October 6, 2023
First Submitted That Met QC Criteria
December 3, 2023
First Posted (Actual)
December 5, 2023
Study Record Updates
Last Update Posted (Actual)
April 10, 2024
Last Update Submitted That Met QC Criteria
April 8, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TJ-IRB202308105
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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