Acute Kidney InjuryNCT02967263
Etiology, Epidemiology and Prognostics of AKI
An observational study of Acute Kidney Injury, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
To investigate the etiology and epidemiology of acute kidney injury (AKI). To find out risk factors associated with the occurence of AKI. To find out risk factors related to the prognosis of AKI,focusing on uremic toxins, inflammation, oxidative stress and nutritional status. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 713 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to 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 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: adult patients aged >18 years, with hospital-acquired acute kidney injury, from a university-affiliated hospital in Shanghai, China.
Who may be able to join
- age >=18 years and <= 88 years
- clinically diagnosed with acute kidney injury, according KDIGO criteria.
Who cannot join
- preexisting chronic kidney failure (defined as an eGFR <60 ml/min per 1.73 m2)
- post-renal obstruction or rapid progressive glomerulonephritis as the main cause of AKI
- known acute renal dysfunction
- hospital stays <24 hours
- malignancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, 200011
Ding Feng, PhD, 86-21-53315165, dingfeng@sjtu.edu.cn
Wenji Wang, MD
About this study
Official title: The Study of Etiology, Epidemiology and Prognostic Factors of Acute Kidney Injury
- To investigate the etiology and epidemiology of acute kidney injury (AKI).
- To find out risk factors associated with the occurence of AKI.
- To find out risk factors related to the prognosis of AKI,focusing on uremic toxins, inflammation, oxidative stress and nutritional status.
- To study on the relationship between gene polymorphism and prognosis of acute kidney injury.
Read the detailed description
- To investigate the relationship between preexisting protein-energy wasting (PEW) and adverse outcomes in patients with AKI.
- To evaluate the association of serum nutritional variables and prognosis of AKI.
- Given the different half-lives of serum nutritional markers, we hypothesized that the utility of serum nutritional variables as prognostic predictors may differ in early death (<7 days) and late death (>7 days, <28 days) patients.
- To investigate the various kinds of uremic toxins in AKI, furthermore, to evaluate the relationship between uremic toxins, especially protein bound toxins, and short- or long-term mortality in AKI patients.
- To investigate the mineral bone disorders in AKI,and to evaluate whether these markers would role as prognostic predictors of AKI.
- Several risk factors of mortality in AKI,such as markers of PEW, inflammation and serum creatinine,have been used; however, no single indicator is considered to be a "gold standard."
- Conditions
- Acute Kidney Injury
- Keywords
- Acute Kidney Injury, Proteinosis, Epidemiology, Risk factors
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Hospital-acquired AKI | Adult patients with Hospital-acquired AKI |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
Measured: 90 days
Secondary outcomes (2)
renal function survival rate
Measured: 90 days
days in hospital
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startJan 2015
- Primary completionJun 2024 (estimated)
- Study completionJun 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.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe 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
- 713 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding Feng, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Feng Ding, PhD, Study director, Division of Nephrology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967263
- Sponsor's protocol ID
- AKI-2016-01
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2016
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Etiology, Epidemiology and Prognostic Factors of Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT02967263
- Acronym / sponsor ID
- AKI-2016-01
- Conditions
- Acute Kidney Injury
- Keywords
- Acute Kidney Injury, Proteinosis, Epidemiology, Risk factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 713 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 18 Nov 2016 (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.
- To investigate the etiology and epidemiology of acute kidney injury (AKI).
- To find out risk factors associated with the occurence of AKI.
- To find out risk factors related to the prognosis of AKI,focusing on uremic toxins, inflammation, oxidative stress and nutritional status.
- To study on the relationship between gene polymorphism and prognosis of acute kidney injury.
Detailed description
- To investigate the relationship between preexisting protein-energy wasting (PEW) and adverse outcomes in patients with AKI.
- To evaluate the association of serum nutritional variables and prognosis of AKI.
- Given the different half-lives of serum nutritional markers, we hypothesized that the utility of serum nutritional variables as prognostic predictors may differ in early death (<7 days) and late death (>7 days, <28 days) patients.
- To investigate the various kinds of uremic toxins in AKI, furthermore, to evaluate the relationship between uremic toxins, especially protein bound toxins, and short- or long-term mortality in AKI patients.
- To investigate the mineral bone disorders in AKI,and to evaluate whether these markers would role as prognostic predictors of AKI.
- Several risk factors of mortality in AKI,such as markers of PEW, inflammation and serum creatinine,have been used; however, no single indicator is considered to be a "gold standard."
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospital-acquired AKI | – | –Adult patients with Hospital-acquired AKI |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients aged >18 years, with hospital-acquired acute kidney injury, from a university-affiliated hospital in Shanghai, China.
Key inclusion criteria (2 listed)
- age >=18 years and <= 88 years
- clinically diagnosed with acute kidney injury, according KDIGO criteria.
Key exclusion criteria (5 listed)
- preexisting chronic kidney failure (defined as an eGFR <60 ml/min per 1.73 m2)
- post-renal obstruction or rapid progressive glomerulonephritis as the main cause of AKI
- known acute renal dysfunction
- hospital stays <24 hours
- malignancy
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
all-cause mortality
Time frame: 90 days
2 secondary outcomes
renal function survival rate
Time frame: 90 days
days in hospital
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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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.
Feng Ding, PhD study director
Division of Nephrology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
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 Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University 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 5 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 28 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Ding, PhD (86-21-53315165, dingfeng@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: 90 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 28 Nov 2023.