|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02544490 |
|
Date of registration:
|
29/08/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Defining Circulating Micro-RNA Biomarkers for the Early Diagnosis and Prognosis of Sepsis
miRNA-Sepsis |
|
Scientific title:
|
Defining Circulating Micro-RNA Biomarkers for the Early Diagnosis and Prognosis of Sepsis |
|
Date of first enrolment:
|
September 2013 |
|
Target sample size:
|
450 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02544490 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Singapore
| | | | | | | |
|
Contacts
|
|
Name:
|
Win Sen Kuan, MBBS |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
National University Hospital, Singapore |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion criteria for controls:
- Adults 21 years and above
- Has condition unrelated to any infective cause
Exclusion criteria for controls:
- Underlying chronic inflammatory condition (e.g. inflammatory bowel disease)
- Underlying autoimmune disease (e.g. rheumatoid arthritis, systemic lupus
erythematosus)
- Pre-existent immunological disorder
Inclusion criteria for subjects:
- Adults 21 years and above
- Clinical/radiological suspicion or confirmation of infection
Exclusion criteria for subjects:
- Age below 21 years
- Prisoners
- Known pregnancy
- Do-not-attempt resuscitation status
- Requirement for immediate surgery
- Active chemotherapy
- Hematological malignancy
- Treating physician deems aggressive care unsuitable
- Unable to provide informed consent or comply with study requirements
Age minimum:
21 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Sepsis
|
|
Primary Outcome(s)
|
|
Fold changes of miRNA expression
[Time Frame: 3 years]
|
|
Secondary Outcome(s)
|
|
MiRNA panel test performance metrics
[Time Frame: 3 years]
|
|
Secondary ID(s)
|
|
TA/0029/2014
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|