Critical IllnessNCT06156098
Bedside Renal Ultrasound Assessment in Patients With Acute Kidney Injury
An observational study of Critical Illness, run by Qin Zhang at 1 site in China.
Trial summary
Exploring the predictive and evaluative value of various indicators of bedside critical renal ultrasound in critically ill patients with acute kidney injury (AKI) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Critical Illness
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 30 Sep 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 18 to 70 years
- All sexes
- Adult, Older adult
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,
Who may be able to join
- Age ≥ 18 years and ≤ 70 years
- Criteria for sepsis patients
Who cannot join
- Pregnant women.
- Patients with malignant tumors, severe heart failure, chronic renal insufficiency, end stage renal disease, kidney transplantation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Qin Zhang, phd, 15717154768, qzhang8@tjh.tjmu.edu.cn
Xiao Ran, phd, 15926207366, ranxiao1001@tjh.tjmu.edu.cn
About this study
Official title: 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)
Read the 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.
- Conditions
- Critical Illness
- Being tested
- No Intervention
- Keywords
- Critical Illness, Ultrasound Therapy, Kidney injury
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
28-day mortality rate
Measured: 28 days
Secondary outcomes (1)
AKI
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Sep 2023
- Primary completion30 Nov 2023
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qin Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qin Zhang, Tongji Hospital
- Investigators
- Qin Zhang, phd, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156098
- Sponsor's protocol ID
- TJ-IRB202308105
- Status last verified
- Apr 2024
- First submitted
- 6 Oct 2023
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Renal Ultrasound Assessment in Critically Ill Patients With Acute Kidney Injury: an Observational Study
- ClinicalTrials.gov ID
- NCT06156098
- Acronym / sponsor ID
- TJ-IRB202308105
- Conditions
- Critical Illness
- Keywords
- Critical Illness, Ultrasound Therapy, Kidney injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qin ZhangUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 5 Dec 2023 (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.
Exploring the predictive and evaluative value of various indicators of bedside critical renal ultrasound in critically ill patients with acute kidney injury (AKI)
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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,
Key inclusion criteria (2 listed)
- Age ≥ 18 years and ≤ 70 years
- Criteria for sepsis patients
Key exclusion criteria (2 listed)
- Pregnant women.
- Patients with malignant tumors, severe heart failure, chronic renal insufficiency, end stage renal disease, kidney transplantation.
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 |
|---|---|---|
| No InterventionNo Intervention | Other | – |
Primary outcome
Survival
Time frame: 28 days
28-day mortality rate
1 secondary outcome
AKI
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
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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.
Qin Zhang, phd principal investigator
Tongji 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 Critical Illness, run by Qin Zhang 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 2 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 10 Apr 2024. 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 Xiao Zhang, phd (15926207366, ranxiao1001@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 28 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 10 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.