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Trial registered on ANZCTR


Registration number
ACTRN12614001284651
Ethics application status
Approved
Date submitted
13/11/2014
Date registered
9/12/2014
Date last updated
15/02/2019
Date data sharing statement initially provided
15/02/2019
Date results information initially provided
15/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
biomarkers in the diagnosis and prognosis in septic acute kidney injury
Scientific title
Serum and urine biomarkers are compared in septic patients with acute renal injury to nonseptic, non acute renal injury in surgical ICU setting
Secondary ID [1] 285657 0
nil
Universal Trial Number (UTN)
U1111-1164-0664
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sepsis
293504 0
acute renal injury 293505 0
Condition category
Condition code
Renal and Urogenital 293782 293782 0 0
Kidney disease
Infection 293899 293899 0 0
Other infectious diseases
Inflammatory and Immune System 293900 293900 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Urine samples will be collected from existing foley cathethers and blood samples collected from arterial catheters from enrolled patients who are recognized as having sepsis with acute renal injury, from admission and every other day for up to 10 days or until these patients are discharged to ward from ICU or deceased.
Intervention code [1] 290598 0
Not applicable
Comparator / control treatment
Patients included in the study will be grouped into four as:
(1) sepsis and milder forms of AKI (Risk and Injury),
(2) sepsis and more severe AKI (Failure, Loss of kidney function and ESRD),
(3) non-sepsis and non-AKI and
(4) sepsis and non-AKI.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293581 0
serum and urine concentrations of biomarkers(NGAL,IL-18, KIM-1, calprotectin),corresponding to the progression/regression of AKI
Timepoint [1] 293581 0
from admission and then every other day during ICU stay until discharge from ICU or death
Secondary outcome [1] 311396 0
prediction of AKI development on admission to ICU; AKI will be defined using RIFLE criteria and patients' RIFLE status will be assessed on the same day as the urine/blood samples are obtained
Timepoint [1] 311396 0
concentration of serum and urine biomarkers on ICU admission; concentration will be assessed using appropriate ELISA kit for each biomarker

Eligibility
Key inclusion criteria
>18 years old without known previous renal diseases admitted to our surgical ICU in the absence of any one of the exclusion criteria
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Urinary tract infection on admission
2. Chronic kidney disease (glomerular filtration rate <60ml/min/1.73m2) for more than 3 months)
3. Patients requiring routine dialysis program
4. Renal transplantation
5. Inflammatory bowel disease

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
The independent samples t-test, chi-square test and Mann-Whitney U tests will be used for categorical and continuous variables. The biomarkers among the 4 groups will be evaluated and compared with ANOVA analysis. Receiver-operating characteristic (ROC) curves will be used to determine the cutoff values of urine biomarkers for the prediction in progression/recovery of septic AKI and development of septic AKI. The area under ROC curve (AUC) will be used to obtain the specificities and sensitivities of the tests.
The number of participants expected to enroll the study is calculated based on the number of ICU patients per year in 12-bed surgical ICU at our hospital. We aim to enroll
(1) 60 sepsis and milder forms of AKI patients(Risk and Injury),
(2) 60 sepsis and more severe AKI patients (Failure, Loss of kidney function and ESRD),
(3) 20 non-sepsis and non-AKI patients and
(4) 40 sepsis and non-AKI patients.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6472 0
Taiwan, Province Of China
State/province [1] 6472 0
Taiwan

Funding & Sponsors
Funding source category [1] 290240 0
Hospital
Name [1] 290240 0
Chang Gung Memorial Hospital
Address [1] 290240 0
Chang Gung Memorial Hospital
No.5, Fu-Hsin Street, Guei-Shan Town, Tao-yuan County, Taiwan
Country [1] 290240 0
Taiwan, Province Of China
Primary sponsor type
Individual
Name
Dr. Hsin-I Tsai
Address
Chang Gung Memorial Hospital
No.5, Fu-Hsin Street, Guei-Shan Town, Tao-yuan County, Taiwan
Country
Taiwan, Province Of China
Secondary sponsor category [1] 288946 0
None
Name [1] 288946 0
Address [1] 288946 0
Country [1] 288946 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291942 0
CGMH IRB
Ethics committee address [1] 291942 0
No.5, Fu-Hsin Street, Guei-Shan Town, Tao-yuan County, Taiwan
Ethics committee country [1] 291942 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 291942 0
Approval date [1] 291942 0
21/08/2014
Ethics approval number [1] 291942 0
103-2722A3

Summary
Brief summary
Severe sepsis is one of the leading causes of acute kidney injury (AKI). Of patients with sepsis in the ICU, 31–61% have AKI. Both the incidence of severe sepsis and AKI are increasing. Patients with septic AKI have worse outcome than septic patients without AKI in terms of longer ICU and hospital stays and higher mortality. Because the current RIFLE classification does not integrate biomarkers for early diagnosis, severity staging and predicting prognosis of AKI, the present study will be conducted to determine the association between some biomarkers in predicting the progression or recovery of septic AKI.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52754 0
Dr Hsin-I Tsai
Address 52754 0
Chang Gung Memorial Hospital
No.5, Fu-Hsin Street, Guei-Shan Town, Tao-yuan county, Taiwan
Country 52754 0
Taiwan, Province Of China
Phone 52754 0
+886 3 328 1200 (transfer to 2324)
Fax 52754 0
Email 52754 0
tsaic@hotmail.com
Contact person for public queries
Name 52755 0
Dr Hsin-I Tsai
Address 52755 0
Chang Gung Memorial Hospital
No.5, Fu-Hsin Street, Guei-Shan Town, Tao-yuan county, Taiwan
Country 52755 0
Taiwan, Province Of China
Phone 52755 0
+886 3 328 1200 (2324)
Fax 52755 0
Email 52755 0
tsaic@hotmail.com
Contact person for scientific queries
Name 52756 0
Dr Hsin-I Tsai
Address 52756 0
Chang Gung Memorial Hospital
No.5, Fu-Hsin Street, Guei-Shan Town, Tao-yuan county, Taiwan
Country 52756 0
Taiwan, Province Of China
Phone 52756 0
+886 3 328 1200 (2324)
Fax 52756 0
Email 52756 0
tsaic@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 1357 0
https://doi.org/10.1186/s13017-018-0202-5
Lee et al. World Journal of Emergency Surgery (2018) 13:41
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary