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

Study Description

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.

Condition or disease
Renal Failure; Nutrition Disorders

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 Design

• Study Type: Observational
• Actual Enrollment: 651 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Study of Etiology, Epidemiology and Prognostic Factors of Acute Kidney Injury
• Study Start Date: April 2009
• Actual Primary Completion Date: December 2018
• Actual Study Completion Date: May 2019

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. renal function survival rate days in the hospital days in the ICU [ Time Frame: discharg from hospital, 28days,90days ]

Biospecimen Retention:   Samples Without DNA

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

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 88 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients selected from a university-affiliated hospital in Shanghai, China.

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

Contacts and Locations

Locations

China

Shanghai Ninth People's Hospital

Shanghai, China, 200011

Sponsors and Collaborators

Huashan Hospital

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Investigators

• Principal Investigator: Feng Ding, professor; Huashan Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Feng Ding,MD, professor, Huashan Hospital
• ClinicalTrials.gov Identifier: NCT00953992
• Other Study ID Numbers: KY2009-107
• First Posted: August 6, 2009
• Last Update Posted: August 22, 2019
• Last Verified: August 2019

Keywords provided by Feng Ding,MD, Huashan Hospital:

acute kidney disease; prognosis; oxidative stress; inflammation; gene polymorphism

Additional relevant MeSH terms:

Acute Kidney Injury; Nutrition Disorders; Renal Insufficiency; Kidney Diseases; Urologic Diseases