Acute Kidney InjuryNCT06241417
Ultrasound to Evaluate Acute Kidney Injury
An observational study of Acute Kidney Injury and Critically Ill, run by Southeast University, China at 1 site in China.
Trial summary
Acute kidney injury is a common complication in critically ill patients. This condition can significantly prolong the length of hospital stay, increase the cost of hospitalization, and have a high mortality rate and a poor prognosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Kidney Injury, Critically Ill
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2024to 30 Jun 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute kidney injury patients in intensive care unit.
Who may be able to join
- Meets diagnostic criteria for AKI (according to KDIGO guidelines); Age ≥ 18 years and ≤ 80 years
Who cannot join
- Chronic kidney disease stage IV-V, maintenance hemodialysis; Kidney tumors; History of kidney transplantation; Nephrectomy; Pregnancy; Arrhythmias that affect the measurement of renal ultrasound.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongda Hospital Affiliated to Southeast University
Nanjing, Jiangsu, 210000
About this study
Official title: Point-of-care Ultrasound to Evaluate Renal Prognosis of Acute Kidney Injury in Critically Ill Patients an Observational Study
Acute kidney injury is a common complication in critically ill patients. This condition can significantly prolong the length of hospital stay, increase the cost of hospitalization, and have a high mortality rate and a poor prognosis. Early assessment of patients' prognosis with acute kidney injury is vital for clinical treatment. Point-of-care ultrasound and renal injury biomarkers can be used to evaluate kidney injury at different levels. Therefore, it is speculated that dynamic monitoring can accurately predict the prognosis of patients with kidney injury.
Read the detailed description
AKI is a common complication in patients with severe disease, significantly prolonging hospital stay, increasing hospital costs, high mortality, and poor prognosis. Epidemiological studies abroad have shown that the incidence of AKI in the intensive care unit (ICU) is about 39%, and the 90-day case fatality rate is 34%.
The renal prognosis of AKI is also a central concern for intensivists, as the renal prognosis also affects the long-term survival outcomes of patients with AKI. In a long-term follow-up of 1538 hospitalized patients, Bhatraju et al. found that in the AKI population, patients who did not recover their renal function during hospitalization had a significantly higher long-term mortality rate than those who recovered.
The main causes of AKI include prerenal factors, renal factors, and postrenal factors. The proportion of AKI caused by postrenal causes in ICU patients is small and can be easily treated and corrected, and prerenal and renal factors are the main causes of AKI in ICU patients. Therefore, the assessment of prerenal and nephrogenic factors in patients with AKI can predict the prognosis of AKI more accurately. An important mechanism of AKI pathogenesis is renal hypoperfusion. Urine output is often used to evaluate renal perfusion in clinical practice, but the specificity of urine output to assess renal perfusion is poor and is affected by factors such as age, stress, surgery, and diuretic use.
Point-of-care ultrasound has the advantages of non-invasive, simple, rapid, and reproducible evaluation, and has been widely used in critically ill patients. Color Doppler ultrasonography and contrast-enhanced ultrasonography can be used to measure renal perfusion parameters and assess renal function. Darmon et al. used renal ultrasound to measure the renal resistance index (RRI) and semi-quantitative renal perfusion (SQP) of renal blood flow in 371 critically ill patients and found that the RRI was significantly higher in patients with AKI than in patients without AKI, but RRI performed poorly in predicting short-term renal prognosis in AKI. Compared with two-dimensional ultrasound, contrast-enhanced ultrasound can visualize changes in renal microcirculation and provide a clearer assessment of renal perfusion. Yoon et al. performed contrast-enhanced renal sonography in 48 patients with AKI and found that the slope of renal cortex washout and peak medulla intensity predicted renal recovery, but the predictive performance was modest.
Novel biomarkers of AKI can identify kidney injury earlier, determine the severity of the injury, and assess prognosis. Komaru et al. measured urinary neutrophil gelatinase-associated lipids transport proteins (NGAL) and serum interleukin-6 levels in 133 patients with AKI requiring continuous renal replacement (CRRT) in the ICU. Urinary NGAL levels at the end of CRRT have been found to predict successful weaning of CRRT.
Based on the above research background, the following scientific hypothesis is proposed: the combination of renal ultrasound and AKI biomarkers can better predict the renal prognosis of AKI patients.
- Conditions
- Acute Kidney Injury, Critically Ill
- Medical subject headings
- Acute Kidney Injury, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| renal recovery | Renal recovery was defined as not satisfied by AKI criteria which was defined by KDIGO. | |
| non renal recovery | Non renal recovery was defined by presenting at least KDIGO Stage 1 criteria or death. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of acute kidney disease
AKD was defined by presenting at least KDIGO Stage 1 criteria for >7 days after enrollment
Measured: Seven days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start25 Jan 2024 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
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.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Xie, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241417
- Sponsor's protocol ID
- 2023ZDSYLL379-P01
- Status last verified
- Feb 2024
- First submitted
- 23 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-care Ultrasound to Evaluate Renal Prognosis of Acute Kidney Injury in Critically Ill Patients an Observational Study
- ClinicalTrials.gov ID
- NCT06241417
- Acronym / sponsor ID
- 2023ZDSYLL379-P01
- Conditions
- Acute Kidney Injury, Critically Ill
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 25 Jan 2024 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 5 Feb 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.
Acute kidney injury is a common complication in critically ill patients. This condition can significantly prolong the length of hospital stay, increase the cost of hospitalization, and have a high mortality rate and a poor prognosis. Early assessment of patients' prognosis with acute kidney injury is vital for clinical treatment. Point-of-care ultrasound and renal injury biomarkers can be used to evaluate kidney injury at different levels. Therefore, it is speculated that dynamic monitoring can accurately predict the prognosis of patients with kidney injury.
Detailed description
AKI is a common complication in patients with severe disease, significantly prolonging hospital stay, increasing hospital costs, high mortality, and poor prognosis. Epidemiological studies abroad have shown that the incidence of AKI in the intensive care unit (ICU) is about 39%, and the 90-day case fatality rate is 34%.
The renal prognosis of AKI is also a central concern for intensivists, as the renal prognosis also affects the long-term survival outcomes of patients with AKI. In a long-term follow-up of 1538 hospitalized patients, Bhatraju et al. found that in the AKI population, patients who did not recover their renal function during hospitalization had a significantly higher long-term mortality rate than those who recovered.
The main causes of AKI include prerenal factors, renal factors, and postrenal factors. The proportion of AKI caused by postrenal causes in ICU patients is small and can be easily treated and corrected, and prerenal and renal factors are the main causes of AKI in ICU patients. Therefore, the assessment of prerenal and nephrogenic factors in patients with AKI can predict the prognosis of AKI more accurately. An important mechanism of AKI pathogenesis is renal hypoperfusion. Urine output is often used to evaluate renal perfusion in clinical practice, but the specificity of urine output to assess renal perfusion is poor and is affected by factors such as age, stress, surgery, and diuretic use.
Point-of-care ultrasound has the advantages of non-invasive, simple, rapid, and reproducible evaluation, and has been widely used in critically ill patients. Color Doppler ultrasonography and contrast-enhanced ultrasonography can be used to measure renal perfusion parameters and assess renal function. Darmon et al. used renal ultrasound to measure the renal resistance index (RRI) and semi-quantitative renal perfusion (SQP) of renal blood flow in 371 critically ill patients and found that the RRI was significantly higher in patients with AKI than in patients without AKI, but RRI performed poorly in predicting short-term renal prognosis in AKI. Compared with two-dimensional ultrasound, contrast-enhanced ultrasound can visualize changes in renal microcirculation and provide a clearer assessment of renal perfusion. Yoon et al. performed contrast-enhanced renal sonography in 48 patients with AKI and found that the slope of renal cortex washout and peak medulla intensity predicted renal recovery, but the predictive performance was modest.
Novel biomarkers of AKI can identify kidney injury earlier, determine the severity of the injury, and assess prognosis. Komaru et al. measured urinary neutrophil gelatinase-associated lipids transport proteins (NGAL) and serum interleukin-6 levels in 133 patients with AKI requiring continuous renal replacement (CRRT) in the ICU. Urinary NGAL levels at the end of CRRT have been found to predict successful weaning of CRRT.
Based on the above research background, the following scientific hypothesis is proposed: the combination of renal ultrasound and AKI biomarkers can better predict the renal prognosis of AKI patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| renal recovery | – | –Renal recovery was defined as not satisfied by AKI criteria which was defined by KDIGO. |
| non renal recovery | – | –Non renal recovery was defined by presenting at least KDIGO Stage 1 criteria or death. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute kidney injury patients in intensive care unit.
Key inclusion criteria (1 listed)
- Meets diagnostic criteria for AKI (according to KDIGO guidelines); Age ≥ 18 years and ≤ 80 years
Key exclusion criteria (1 listed)
- Chronic kidney disease stage IV-V, maintenance hemodialysis; Kidney tumors; History of kidney transplantation; Nephrectomy; Pregnancy; Arrhythmias that affect the measurement of renal ultrasound.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of acute kidney disease
Time frame: Seven days after enrollment
AKD was defined by presenting at least KDIGO Stage 1 criteria for >7 days after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Critically Ill, run by Southeast University, China 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 1 inclusion and 1 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 5 Feb 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?
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?
Rate of acute kidney disease (time frame: Seven days after enrollment). 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 5 Feb 2024.