Acute Kidney InjuryNCT04555382
Combining CAF, L-FABP and NGAL as a Potentially Diagnostic Model for Acute Kidney Injury.
An observational study of Acute Kidney Injury, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Acute kidney injury was a common clinical complication, and many diseases were associated with a high risk of occurrence of AKI. We explored the clinical utility of serum CAF, L-FABP and NGAL by constructing a diagnostic model for identification of ICU patients at risk for AKI and distinguish different etiologies of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Blood and Urine
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2020to 15 Aug 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The objects of study are the patients from the intensive care unit of the Second Affiliated Hospital of Zhejiang University School of Medicine between August 2020 and August 2022.
Who may be able to join
- the serum creatinine was increased above reference range at first when patients were included intensive care unit;
- renal dialysis and plasma exchange were never occured when patients were included in the study;
- patients who were included in the study stayed at two days in ICU.
Who cannot join
- patients who stayed in ICU for less than 24 hours;
- the serum creatinine was increased above reference range before ICU admission;
- kidney-related diseases were existed before ICU admission.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
Wang Weilin, +86 0571 87783759, keyanlunli_zheer@163.com
About this study
Official title: Association Between CAF, L-FABP and NGAL and the Occurence of Acute Kidney Injury : a Potential Diagnostic Model of Three Biomarkers.
Acute kidney injury was a common clinical complication, and many diseases were associated with a high risk of occurrence of AKI. We explored the clinical utility of serum CAF, L-FABP and NGAL by constructing a diagnostic model for identification of ICU patients at risk for AKI and distinguish different etiologies of AKI.
This observational cohort study included one hundred patients who had been in ICU from the Second Affiliated Hospital of Zhejiang University School of Medicine between August 2020 and August 2022. Blood and urine samples were collected every 12 hours until 7 days. The time of staying with ICU less than 2 days were removed. CAF, L-FABP and NGAL was measured based on the platform of Chemiluminescent Immunoassay, and assessed the diagnostic value of the occurrence of AKI. By constructing an effective diagnostic model to provide effective clinical decision-marking for early intervention.
Read the detailed description
The observational cohort study included one hundred patients who were from the intensive care unit of the Second Affiliated Hospital of Zhejiang University School of Medicine between August 2020 and August 2022. AKI was defined according to the Kidney Disease Improving Global Outcomes (KDIGO) guidelines as renal function was suddenly decreased within 48 hours and serum creatinine increased at least 0.3mg/dL, or serum creatinine increased more than 1.5 times higher than baseline within 7 days, or urine volume less than 0.5mL/Kg per hour for 6 hours. The staging criteria of AKI as follows: stage I means serum creatinine higher than baseline between 1.5times and 1.9 times, or serum creatinine increased at least 26.5μmol/L, or serum creatinine increased more than 1.5 times higher than baseline within 7 days, or urine volume less than 0.5mL/Kg per hour for 6 hours; stage II means serum creatinine higher than baseline between 2.0 times and 2.9 times, or urine volume less than 0.5mL/Kg per hour for 12hours; stage III means serum creatinine higher than baseline 3.0 times, or serum creatinine higher than baseline 353.6μmol/L, or started renal replacement therapy. Patients who stayed in the ICU for less than 24 hours and whose serum creatinine had increased above normal reference range on the first day of ICU were excluded.
Collecting the blood and urine samples of the patients regularly every twelve hours, centrifuging samples in 3000rpm for 5 minutes, freezing at -80℃, all patients' clinical information should be recorded by name, age ,sex, BMI index, hypertension, diabetes, cardiac disease, and so on. All patients have written informed contents and this study was approved by the Second Affiliated Hospital of Zhejiang University School of Medicine.NGAL, CAF and L-FABP was measured by chemiluminescent immunoassay with Robust i1000.
- Conditions
- Acute Kidney Injury
- Being tested
- Blood and Urine
- Keywords
- L-FABP, Acute Kidney Injury, diagnosis, biomarker
- Medical subject headings
- Acute Kidney Injury, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and UrineDiagnostic test
Blood and urine samples are collected every twelve hours when the patients are included in the study during observation period.
| Study group | Role | What they receive |
|---|---|---|
| AKI group | this group are included patients who have not occured acute kidney injury at first, however acute kidney injury are occured soon afterwards during the observation period. Receives: Diagnostic Test: Blood and Urine | |
| non-AKI group | this group are included patients who have not occured acute kidney injury during the observation period. Receives: Diagnostic Test: Blood and Urine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the concentration of CAF, L-FABP and NGAL
the concentration of CAF, L-FABP and NGAL of blood and urine samples of every patients are measured by Chemiluminescent Immunoassay
Measured: seven days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start15 Aug 2020
- Primary completion15 Feb 2022 (estimated)
- Study completion15 Aug 2022 (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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Zhihua, Study chair, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555382
- Sponsor's protocol ID
- 2020-791
- Status last verified
- Sep 2020
- First submitted
- 15 Sep 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between CAF, L-FABP and NGAL and the Occurence of Acute Kidney Injury : a Potential Diagnostic Model of Three Biomarkers.
- ClinicalTrials.gov ID
- NCT04555382
- Acronym / sponsor ID
- 2020-791
- Conditions
- Acute Kidney Injury
- Keywords
- L-FABP, Acute Kidney Injury, diagnosis, biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 15 Feb 2022 (estimated)
- Study completion
- 15 Aug 2022 (estimated)
- First posted
- 18 Sep 2020 (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 was a common clinical complication, and many diseases were associated with a high risk of occurrence of AKI. We explored the clinical utility of serum CAF, L-FABP and NGAL by constructing a diagnostic model for identification of ICU patients at risk for AKI and distinguish different etiologies of AKI.
This observational cohort study included one hundred patients who had been in ICU from the Second Affiliated Hospital of Zhejiang University School of Medicine between August 2020 and August 2022. Blood and urine samples were collected every 12 hours until 7 days. The time of staying with ICU less than 2 days were removed. CAF, L-FABP and NGAL was measured based on the platform of Chemiluminescent Immunoassay, and assessed the diagnostic value of the occurrence of AKI. By constructing an effective diagnostic model to provide effective clinical decision-marking for early intervention.
Detailed description
The observational cohort study included one hundred patients who were from the intensive care unit of the Second Affiliated Hospital of Zhejiang University School of Medicine between August 2020 and August 2022. AKI was defined according to the Kidney Disease Improving Global Outcomes (KDIGO) guidelines as renal function was suddenly decreased within 48 hours and serum creatinine increased at least 0.3mg/dL, or serum creatinine increased more than 1.5 times higher than baseline within 7 days, or urine volume less than 0.5mL/Kg per hour for 6 hours. The staging criteria of AKI as follows: stage I means serum creatinine higher than baseline between 1.5times and 1.9 times, or serum creatinine increased at least 26.5μmol/L, or serum creatinine increased more than 1.5 times higher than baseline within 7 days, or urine volume less than 0.5mL/Kg per hour for 6 hours; stage II means serum creatinine higher than baseline between 2.0 times and 2.9 times, or urine volume less than 0.5mL/Kg per hour for 12hours; stage III means serum creatinine higher than baseline 3.0 times, or serum creatinine higher than baseline 353.6μmol/L, or started renal replacement therapy. Patients who stayed in the ICU for less than 24 hours and whose serum creatinine had increased above normal reference range on the first day of ICU were excluded.
Collecting the blood and urine samples of the patients regularly every twelve hours, centrifuging samples in 3000rpm for 5 minutes, freezing at -80℃, all patients' clinical information should be recorded by name, age ,sex, BMI index, hypertension, diabetes, cardiac disease, and so on. All patients have written informed contents and this study was approved by the Second Affiliated Hospital of Zhejiang University School of Medicine.NGAL, CAF and L-FABP was measured by chemiluminescent immunoassay with Robust i1000.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI group | – | Diagnostic Test: Blood and Urinethis group are included patients who have not occured acute kidney injury at first, however acute kidney injury are occured soon afterwards during the observation period. |
| non-AKI group | – | Diagnostic Test: Blood and Urinethis group are included patients who have not occured acute kidney injury during the observation period. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The objects of study are the patients from the intensive care unit of the Second Affiliated Hospital of Zhejiang University School of Medicine between August 2020 and August 2022.
Key inclusion criteria (3 listed)
- the serum creatinine was increased above reference range at first when patients were included intensive care unit;
- renal dialysis and plasma exchange were never occured when patients were included in the study;
- patients who were included in the study stayed at two days in ICU.
Key exclusion criteria (3 listed)
- patients who stayed in ICU for less than 24 hours;
- the serum creatinine was increased above reference range before ICU admission;
- kidney-related diseases were existed before ICU admission.
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 |
|---|---|---|
| Blood and UrineBlood and urine samples are collected every twelve hours when the patients are included in the study during observation period. | Diagnostic test | AKI group, non-AKI group |
Primary outcome
the concentration of CAF, L-FABP and NGAL
Time frame: seven days after admission
the concentration of CAF, L-FABP and NGAL of blood and urine samples of every patients are measured by Chemiluminescent Immunoassay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Tao Zhihua study chair
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
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 Second Affiliated Hospital, Zhejiang University, School of Medicine 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 3 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 8 Oct 2020. 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 Sun Tao (15858168218, stzr@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the concentration of CAF, L-FABP and NGAL (time frame: seven days after admission). 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 8 Oct 2020.