Clinical trial NCT00953992: Etiology, Epidemiology and Prognostics of Acute Kidney Injury (AKI)
Official title: The Study of Etiology, Epidemiology and Prognostic Factors of Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Failure
Nutrition Disorders
Keywords: acute kidney disease
prognosis
oxidative stress
inflammation
gene polymorphism
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
First posted: 2009-08-06
Enrollment: 651
Sex: ALL
Minimum age (years): 16
Maximum age (years): 88
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients selected from a university-affiliated hospital in Shanghai, China.

Brief 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.
* To study on the relationship between gene polymorphism and prognosis of acute kidney injury.

Detailed description: 1. 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."
2. to evaluate the association of serum nutritional variables and prognosis of acute kidney injury
3. 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.

Eligibility criteria: Inclusion Criteria:

* age \>=16 years and \<= 88 years
* clinically diagnosed with acute kidney injury, according RIFLE or KDIGO criteria.

Exclusion Criteria:

* 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

Primary outcomes:
measure: renal function survival rate days in the hospital days in the ICU
timeFrame: discharg from hospital, 28days,90days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
Study officials:
affiliation: Huashan Hospital
name: Feng Ding, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Yang 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.
citation: Gong 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.
citation: Wang 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.