Etiology, Epidemiology and Prognostics of Acute Kidney Injury (AKI)

• ClinicalTrials.gov Identifier: NCT00953992
• Recruitment Status: Completed
• First Posted: August 6, 2009
• Last Update Posted: August 22, 2019
• Sponsor: Huashan Hospital
• Collaborator: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Information provided by (Responsible Party): Feng Ding,MD, Huashan Hospital

Tracking Information

• First Submitted Date: August 5, 2009
• First Posted Date: August 6, 2009
• Last Update Posted Date: August 22, 2019
• Study Start Date: April 2009
• Actual Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 5, 2009): renal function survival rate days in the hospital days in the ICU [ Time Frame: discharg from hospital, 28days,90days ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Etiology, Epidemiology and Prognostics of Acute Kidney Injury (AKI)
• Official Title: The Study of Etiology, Epidemiology and Prognostic Factors of Acute Kidney Injury

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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

1ml whole blood and 1ml serum will obtained within 24 hour after AKI for hematological and biochemistry analyze.

• Sampling Method: Non-Probability Sample
• Study Population: Patients selected from a university-affiliated hospital in Shanghai, China.

Condition

• Renal Failure
• Nutrition Disorders

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 21, 2019): 651
• Original Estimated Enrollment (submitted: August 5, 2009): 300
• Actual Study Completion Date: May 2019
• Actual Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years to 88 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT00953992
• Other Study ID Numbers: KY2009-107
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Feng Ding,MD, Huashan Hospital
• Original Responsible Party: Feng Ding, Huashan hospital
• Current Study Sponsor: Huashan Hospital
• Original Study Sponsor: Same as current
• Collaborators: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Investigators

• Principal Investigator: Feng Ding, professor; Huashan Hospital

• PRS Account: Huashan Hospital
• Verification Date: August 2019