Defining Circulating Micro-RNA Biomarkers for the Early Diagnosis and Prognosis of Sepsis

NCT02544490 | Completed

• 1 other identifier: TA/0029/2014
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives are to:

1. 1.derive and validate a panel of miRNAs that are consistently differentially expressed in the plasma of patients with and without sepsis
2. 2.investigate the prognostic and predictive values of the panel of miRNAs to guide treatment
3. 3.investigate the roles of these differentially-expressed circulating miRNAs in immune modulation during sepsis

Conditions

Sepsis

Keywords

Sepsis; MicroRNAs; Diagnosis; Prognosis

Outcome Measures

Primary Outcomes (1)

• Fold changes of miRNA expression

  Fold changes of differentially-expressed miRNA in log2 scale in comparison to the severity of sepsis (control vs. sepsis vs. septic shock) and adjudicated requirement for hospitalization (yes vs. no)

  3 years

Secondary Outcomes (1)

• MiRNA panel test performance metrics

  3 years

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This research project will be a prospective observational cohort study of controls without infection and patients along the entire sepsis continuum the Emergency Department (ED). Admitted patients will be followed-up in the inpatient units including the intensive care unit (ICU) and general wards. Healthy controls and those with systemic inflammatory response syndrome (SIRS) but without evidence of infection will also be recruited to demonstrate differentiation of biomarkers for early diagnosis. The reference standards for infection and sepsis will be positive cultures (e.g. from blood, urine, endotracheal tube, sputum) and final discharge diagnoses.

You may qualify if:

• Adults 21 years and above
• Has condition unrelated to any infective cause

You may not qualify if:

• Underlying chronic inflammatory condition (e.g. inflammatory bowel disease)
• Underlying autoimmune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus)
• Pre-existent immunological disorder
• Adults 21 years and above
• Clinical/radiological suspicion or confirmation of infection
• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University of Singapore: collaborator
• MiRXES Pte Ltd: collaborator
• A*Star: collaborator

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood extraction from subjects subsequently separated to plasma and serum that are stored in the Tissue Repository.

MeSH Terms

Conditions

Sepsis; Disease

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Win Sen Kuan, MBBS

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: August 29, 2015
• First Posted: September 9, 2015
• Study Start: September 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

SG (1)