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Dynamic Monitoring of Circulating microRNA Changes in Patients With or Without Multiple Organ Failure

Dynamic Monitoring of Circulating microRNA Changes in Patients With or Without Multiple Organ Failure

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03059524
Enrollment
200
Registered
2017-02-23
Start date
2017-01-31
Completion date
2018-12-31
Last updated
2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Organ Failure

Keywords

microRNA

Brief summary

The objectives are to: 1. validate a panel of tissue-specific miRNAs that are differentially expressed in the plasma of patients with and without multiple organ failure. 2. investigate the dysregulation of circulating miRNA panel and their prognostic and predictive values in clinical outcomes in identifying patients at high risk for mortality and multiple organ failure. This trial involves peripheral blood sampling from subjects at their earliest presentation and remaining stays in the hospitalization in the emergency department. The investigators will develop panels of miRNAs that are specific indicator of early onset of major organ failures, and correlate clinical outcomes with these miRNAs.

Detailed description

The ICU patients with multiple organ failure in sponsor's institutes will be enrolled in this observational cohort of investigation. Whole blood samples will be separated immediately into plasma for storage. The participants will have their 2nd and 3rd samples obtained at 24-48 hours and 48-72 hours respectively. The schedule of most of sampling schedule is designed in concordance with the ICU routines to avoid extra burdens on patients. The plasma samples will be used as prognostic markers in prognostic and predictive values in identifying patients at high risk for mortality and multiple organ failure. Patients who are discharged will be tracked for any clinical recurrence of the diseases every 28 days to assess the diagnostic accuracy of the miRNA biomarkers that are measured. The 2nd objective will be assessed by measuring the concentration of miRNAs in normal patients without multiple organ failure. The circulating miRNAs will be detected directly from 1 - 5 ul of plasma samples with the miRFLP assay. This capillary electrophoresis-based miRNA quantification method detects multiple miRNAs in absolute copy number in smaller sample signature with negligible batch to batch variation, thus providing a standard miRNA detection method.

Interventions

None listed

Sponsors

Chengdu Nuoen Biotechnologies, Inc.
CollaboratorOTHER
University of Electronic Science and Technology of China
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

for subjects: * Adults 18 years and above * Has condition related to ICU enrollment cause

Exclusion criteria

for subjects: * Age below 18 years * Known pregnancy * Treating physician deems aggressive care unsuitable * Unable to provide informed consent or comply with study requirements Inclusion criteria for normal controls: • Adults 18 years and above

Design outcomes

Primary

MeasureTime frameDescription
The concentration of circulating miRNA expression quantitated in absolute copy numbers in ICU patients with or without multiple organ failures.3 yearsThe circulating miRNA concentration is to be measured in patient plasma samples with or without multiple organ failures. The comparison of miRNA expression will be performed to investigate the potential prognostic value of the miRNA panel on survival rates at the onset of multiple organ failures.

Countries

China

Contacts

Primary ContactLiu Zhenjun
84696484@qq.com+ 86-28-85420949

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026