Acute Kidney InjuryNCT03054142
China Collaborative Study on Epidemiology of Acute Kidney Injury
An observational study of Acute Kidney Injury, run by XinLing Liang at 1 site in China.
Trial summary
Acute kidney injury (AKI) is a common clinical syndrome, especially patients in the hospital. AKI has become a huge medical burden in China. Little information is available about this disease burden in our country. The investigators aimed to evaluate the burden of AKI and to analyze the related risk factors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 1,000,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All inpatients (if outpatient identification is achieved, outpatient and inpatient patients can be judged to be the same individual, the outpatient electronic data is extracted at the same time)
Who may be able to join
- The patients diagnosed on the basis of changes in serum creatinine according to the criteria of 2012 Kidney Disease Improving Global Outcomes(KDIGO)
Who cannot join
- Serum creatinine record less than two times during hospitalization
- Patients being diagnosed with End-stage kidney disease (chronic kidney disease stage 5)
- Nephrectomy
- Kidney transplantation
- Peak serum creatinine of less than 53µ mol/L
- Serum creatinine decrease after amputation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nephrology Dept,Guangdong General Hospital
Guangzhou, Guangdong
Liang Xinling, MD,PhD, 86-13808819770, xinlingliang@139.com
About this study
Acute kidney injury (AKI) is a common clinical syndrome, especially patients in the hospital. AKI has become a huge medical burden in China. Little information is available about this disease burden in our country. The investigators aimed to evaluate the burden of AKI and to analyze the related risk factors.
Read the detailed description
The investigators launch a nationwide of all patients, who were admitted to hospital from 2011-2016. Patients were diagnosed on the basis of changes in serum creatinine by the laboratory information system. The investigators assessed rates of AKI according to the criteria of 2012 Kidney Disease Improving Global Outcomes (KDIGO).
- Conditions
- Acute Kidney Injury
- Being tested
- no intervention
- 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.
no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| AKI | Not described Receives: Other: no intervention | |
| non-AKI | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AKI
Measured: Jan. 2011 to Oct. 2016
Secondary outcomes (5)
Recognition rate of AKI
Using machine learning and deep learning methods to establish AKI prediction model and risk models
Measured: Jan. 2011 to Oct. 2016
Proportion of nephrology referral
Measured: Jan. 2011 to Oct. 2016
In-hospital mortality
Measured: Jan. 2011 to Oct. 2016
Longer ICU stay
Measured: Jan. 2011 to Oct. 2016
Higher medical cost
Measured: Jan. 2011 to Oct. 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study startJan 2017
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XinLing Liang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, XinLing Liang, Guangdong Provincial People's Hospital
- Investigators
- Liang Xinling, M.D.,Ph.D, Principal investigator, Nephrology Dept,Guangdong General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054142
- Sponsor's protocol ID
- CCS-AKI RF2011-2016
- Status last verified
- Dec 2022
- First submitted
- 13 Feb 2017
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Xu L, Wu Y, Chen Y, Li R, Wang Z, Li Z, Liu G, Yu L, Shi W, Liang X; China collaborative study on AKI (CCS-AKI). Is acute kidney injury age-dependent in older adults: an observational study in two centers from North China. BMC Geriatr. 2021 Jan 6;21(1):7. doi: 10.1186/s12877-020-01906-z.
PubMed 33407184
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Collaborative Study on Epidemiology of Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT03054142
- Acronym / sponsor ID
- CCS-AKI RF2011-2016
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000,000 participants (estimated)
- Lead sponsor
- XinLing LiangUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Feb 2017 (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 (AKI) is a common clinical syndrome, especially patients in the hospital. AKI has become a huge medical burden in China. Little information is available about this disease burden in our country. The investigators aimed to evaluate the burden of AKI and to analyze the related risk factors.
Detailed description
The investigators launch a nationwide of all patients, who were admitted to hospital from 2011-2016. Patients were diagnosed on the basis of changes in serum creatinine by the laboratory information system. The investigators assessed rates of AKI according to the criteria of 2012 Kidney Disease Improving Global Outcomes (KDIGO).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI | – | Other: no intervention |
| non-AKI | – | Other: no intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All inpatients (if outpatient identification is achieved, outpatient and inpatient patients can be judged to be the same individual, the outpatient electronic data is extracted at the same time)
Key inclusion criteria (1 listed)
- The patients diagnosed on the basis of changes in serum creatinine according to the criteria of 2012 Kidney Disease Improving Global Outcomes(KDIGO)
Key exclusion criteria (6 listed)
- Serum creatinine record less than two times during hospitalization
- Patients being diagnosed with End-stage kidney disease (chronic kidney disease stage 5)
- Nephrectomy
- Kidney transplantation
- Peak serum creatinine of less than 53µ mol/L
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 intervention | Other | AKI, non-AKI |
Primary outcome
Incidence of AKI
Time frame: Jan. 2011 to Oct. 2016
5 secondary outcomes
Recognition rate of AKI
Time frame: Jan. 2011 to Oct. 2016
Proportion of nephrology referral
Time frame: Jan. 2011 to Oct. 2016
In-hospital mortality
Time frame: Jan. 2011 to Oct. 2016
Longer ICU stay
Time frame: Jan. 2011 to Oct. 2016
Higher medical cost
Time frame: Jan. 2011 to Oct. 2016
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Derived from this study: PubMed 33407184Xu L, Wu Y, Chen Y, Li R, Wang Z, Li Z, Liu G, Yu L, Shi W, Liang X; China collaborative study on AKI (CCS-AKI). Is acute kidney injury age-dependent in older adults: an observational study in two centers from North China. BMC Geriatr. 2021 Jan 6;21(1):7. doi: 10.1186/s12877-020-01906-z.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
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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.
Liang Xinling, M.D.,Ph.D principal investigator
Nephrology Dept,Guangdong General 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 Acute Kidney Injury, run by XinLing Liang 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 6 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: looking for participants now, as of the sponsor's last update on 13 Dec 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liang Xinling, M.D.,Ph.D (13808819770, xinlingliang@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AKI (time frame: Jan. 2011 to Oct. 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03054142, which also lists 1 linked publication.
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 13 Dec 2022.