Etiology, Epidemiology and Prognostics of AKI

Acute Kidney Injury Clinical Trial

Official title:

The Study of Etiology, Epidemiology and Prognostic Factors of Acute Kidney Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02967263
• Other study ID #: AKI-2016-01
• Status: Recruiting
• Start date: January 2015
• Est. completion date: June 2024

Study information

• Verified date: November 2023
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: Feng Ding, PhD
• Phone: 86-21-53315165
• Email: dingfeng[@]sjtu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

• To investigate the etiology and epidemiology of acute kidney injury (AKI).

• To find out risk factors associated with the occurence of AKI.

• To find out risk factors related to the prognosis of AKI,focusing on uremic toxins, inflammation, oxidative stress and nutritional status.

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

Description:

1. To investigate the relationship between preexisting protein-energy wasting (PEW) and adverse outcomes in patients with AKI.

2. To evaluate the association of serum nutritional variables and prognosis of AKI.

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.

4. To investigate the various kinds of uremic toxins in AKI, furthermore, to evaluate the relationship between uremic toxins, especially protein bound toxins, and short- or long-term mortality in AKI patients.

5. To investigate the mineral bone disorders in AKI,and to evaluate whether these markers would role as prognostic predictors of AKI.

6. Several risk factors of mortality in AKI,such as markers of PEW, inflammation and serum creatinine,have been used; however, no single indicator is considered to be a "gold standard."

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 713
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• age >=18 years and <= 88 years

• clinically diagnosed with acute kidney injury, according KDIGO criteria.

Exclusion Criteria:

• preexisting chronic kidney failure (defined as an eGFR <60 ml/min per 1.73 m2)

• post-renal obstruction or rapid progressive glomerulonephritis as the main cause of AKI

• known acute renal dysfunction

• hospital stays <24 hours

• malignancy

Related Conditions & MeSH terms

• Acute Kidney Injury

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all-cause mortality		90 days
Secondary	renal function survival rate		90 days
Secondary	days in hospital		90 days