Plasticity and Regeneration of Renal Epithelial Cells
1 other identifier
observational
400
1 country
1
Brief Summary
The incidence of acute kidney injury (AKI) among all hospitalized patients is approximately 7%. Among these patients, sepsis and septic shock remain the most important cause of acute renal failure (ARF) and account for more than 50% of cases of AKI. The goal of this project is to uncover key factors that lead to renal function recovery. This study is planned to survey novel biomarkers that reflect tissue pathology or regeneration. During the hospitalization, blood and urine sample will be collected for NGAL and inflammatory marker analysis in the patients with bacteremia, while the rest sample will be collected for further novel biomarker survey. This study is to early predict the renal function impairment and identify the possible molecule that involved in renal function recovery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2016
CompletedFirst Posted
Study publicly available on registry
June 30, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJune 30, 2016
June 1, 2016
3.4 years
June 21, 2016
June 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline NGAL and KIM-1 at 48-96 hours
Early kidney injury marker using ELISA
Two time point: diagnosed day 1 and 48-96 hours after diagnosed day
Secondary Outcomes (6)
Clinical inflammatory markers, including white cell count and CRP
Two time point: diagnosed day 1 and 48-96 hours after diagnosed day
BUN/Creatinine
Two time point: diagnosed day 1 and 48-96 hours after diagnosed day
SOFA and qSOFA score
Two time point: diagnosed day 1 and 48-96 hours after diagnosed day
Novel proteomics markers (Confidential)
Two time point: diagnosed day 1 and 48-96 hours after diagnosed day
Novel SNP markers (Confidential)
Two time point: diagnosed day 1 and 48-96 hours after diagnosed day
- +1 more secondary outcomes
Study Arms (1)
Bacteremia with Sepsis group
Patients aged 20 years or older with a diagnosis of bacteremia will be eligible for inclusion in the study.
Eligibility Criteria
Patients aged 20 years or older with a diagnosis of bacteremia will be eligible for inclusion in the study.
You may qualify if:
- Newly diagnosed bacteremia with sepsis patients
- Age more than 20 years old
- Sign the Permit
You may not qualify if:
- Predicted not survival longer than 72 hours
- Pregnant woman
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Taiwan
Biospecimen
Serum sample will be collected for further protein, DNA, RNA analysis. Urine sample will also be collected.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
YU-FENG LIN, MD
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2016
First Posted
June 30, 2016
Study Start
July 1, 2016
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
June 30, 2016
Record last verified: 2016-06