Renal FailureNCT00953992
Etiology, Epidemiology and Prognostics of Acute Kidney Injury (AKI)
An observational study of Renal Failure and Nutrition Disorders, run by Huashan Hospital at 1 site in China.
Trial summary
To investigate the etiology, epidemiology and prognostic factors of acute kidney injury. To find out risk factors that relate with the prognosis of acute kidney injury,focusing on inflammation, oxidative stress and nutritional status. Read more about this study
- Who is it for?
- Ages 16 to 88 years
- Conditions the study is for
- Renal Failure, Nutrition Disorders
- How many people
- 651 participants
- Where
- 1 siteChina
- Study dates
- Apr 2009to May 2019
- 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 16 to 88 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients selected from a university-affiliated hospital in Shanghai, China.
Who may be able to join
- age >=16 years and <= 88 years
- clinically diagnosed with acute kidney injury, according RIFLE or KDIGO criteria.
Who cannot join
- acute Renal Failure occurring in the setting of burns, obstructive uropathy, allergic interstitial nephritis, acute or rapidly progressive glomerulonephritis, vasculitis, hemolytic-uremic syndrome, thrombotic thrombocytopenic purpura (TTP), malignant hypertension, scleroderma renal crisis, atheroembolism, functional or surgical nephrectomy, hepatorenal syndrome, cyclosporin or tacrolimus nephrotoxicity
- Do Not Resuscitate (DNR) status
- subjects enrolled in another clinical trial that could affect the outcome of this study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Study of Etiology, Epidemiology and Prognostic Factors of Acute Kidney Injury
- To investigate the etiology, epidemiology and prognostic factors of acute kidney injury.
- To find out risk factors that relate with the prognosis of acute kidney injury,focusing on 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 malnutrition and adverse outcomes in patients with AKI
- Several nutritional assessment methods such as anthropometric, clinical and biochemical evaluations have been used; however, no single indicator is considered to be a "gold standard."
- to evaluate the association of serum nutritional variables and prognosis of acute kidney injury
- 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.
- Conditions
- Renal Failure, Nutrition Disorders
- Keywords
- acute kidney disease, prognosis, oxidative stress, inflammation, gene polymorphism
- Medical subject headings
- Renal Insufficiency, Nutrition Disorders, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
renal function survival rate days in the hospital days in the ICU
Measured: discharg from hospital, 28days,90days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2018
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe 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
- 651 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Ding,MD, Huashan Hospital
- Investigators
- Feng Ding, professor, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953992
- Sponsor's protocol ID
- KY2009-107
- Status last verified
- Aug 2019
- First submitted
- 5 Aug 2009
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gong Y, Ding F, Gu Y. Can Serum Nutritional Related Biomarkers Predict Mortality Of Critically Ill Older Patients With Acute Kidney Injury? Clin Interv Aging. 2019 Oct 18;14:1763-1769. doi: 10.2147/CIA.S218973. eCollection 2019.
PubMed 31695346Yang T, Wang W, Tang X, Shi P, Zhang L, Yu W, Xie Y, Guo D, Ding F. Association between mineral and bone disorder in patients with acute kidney injury following cardiac surgery and adverse outcomes. BMC Nephrol. 2019 Oct 15;20(1):369. doi: 10.1186/s12882-019-1572-y.
PubMed 31615432Gong Y, Ding F, Zhang F, Gu Y. Investigate predictive capacity of in-hospital mortality of four severity score systems on critically ill patients with acute kidney injury. J Investig Med. 2019 Dec;67(8):1103-1109. doi: 10.1136/jim-2019-001003. Epub 2019 Oct 1.
PubMed 31575668Wang W, Hao G, Pan Y, Ma S, Yang T, Shi P, Zhu Q, Xie Y, Ma S, Zhang Q, Ruan H, Ding F. Serum indoxyl sulfate is associated with mortality in hospital-acquired acute kidney injury: a prospective cohort study. BMC Nephrol. 2019 Feb 14;20(1):57. doi: 10.1186/s12882-019-1238-9.
PubMed 30764800
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. 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
- NCT00953992
- Acronym / sponsor ID
- KY2009-107
- Conditions
- Renal Failure, Nutrition Disorders
- Keywords
- acute kidney disease, prognosis, oxidative stress, inflammation, gene polymorphism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 651 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Study start
- Apr 2009
- Primary completion
- Dec 2018 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 6 Aug 2009 (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, epidemiology and prognostic factors of acute kidney injury.
- To find out risk factors that relate with the prognosis of acute kidney injury,focusing on 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 malnutrition and adverse outcomes in patients with AKI
- Several nutritional assessment methods such as anthropometric, clinical and biochemical evaluations have been used; however, no single indicator is considered to be a "gold standard."
- to evaluate the association of serum nutritional variables and prognosis of acute kidney injury
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients selected from a university-affiliated hospital in Shanghai, China.
Key inclusion criteria (2 listed)
- age >=16 years and <= 88 years
- clinically diagnosed with acute kidney injury, according RIFLE or KDIGO criteria.
Key exclusion criteria (3 listed)
- acute Renal Failure occurring in the setting of burns, obstructive uropathy, allergic interstitial nephritis, acute or rapidly progressive glomerulonephritis, vasculitis, hemolytic-uremic syndrome, thrombotic thrombocytopenic purpura (TTP), malignant hypertension, scleroderma renal crisis, atheroembolism, functional or surgical nephrectomy, hepatorenal syndrome, cyclosporin or tacrolimus nephrotoxicity
- Do Not Resuscitate (DNR) status
- subjects enrolled in another clinical trial that could affect the outcome of this study protocol
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
renal function survival rate days in the hospital days in the ICU
Time frame: discharg from hospital, 28days,90days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Derived from this study: PubMed 31695346Gong Y, Ding F, Gu Y. Can Serum Nutritional Related Biomarkers Predict Mortality Of Critically Ill Older Patients With Acute Kidney Injury? Clin Interv Aging. 2019 Oct 18;14:1763-1769. doi: 10.2147/CIA.S218973. eCollection 2019.
- Derived from this study: PubMed 31615432Yang T, Wang W, Tang X, Shi P, Zhang L, Yu W, Xie Y, Guo D, Ding F. Association between mineral and bone disorder in patients with acute kidney injury following cardiac surgery and adverse outcomes. BMC Nephrol. 2019 Oct 15;20(1):369. doi: 10.1186/s12882-019-1572-y.
- Derived from this study: PubMed 31575668Gong Y, Ding F, Zhang F, Gu Y. Investigate predictive capacity of in-hospital mortality of four severity score systems on critically ill patients with acute kidney injury. J Investig Med. 2019 Dec;67(8):1103-1109. doi: 10.1136/jim-2019-001003. Epub 2019 Oct 1.
- Derived from this study: PubMed 30764800Wang W, Hao G, Pan Y, Ma S, Yang T, Shi P, Zhu Q, Xie Y, Ma S, Zhang Q, Ruan H, Ding F. Serum indoxyl sulfate is associated with mortality in hospital-acquired acute kidney injury: a prospective cohort study. BMC Nephrol. 2019 Feb 14;20(1):57. doi: 10.1186/s12882-019-1238-9.
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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, professor principal investigator
Huashan 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 Renal Failure and Nutrition Disorders, run by Huashan Hospital 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 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: finished, as of the sponsor's last update on 22 Aug 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
renal function survival rate days in the hospital days in the ICU (time frame: discharg from hospital, 28days,90days). 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 NCT00953992, which also lists 4 linked publications.
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 22 Aug 2019.