MIRNA QUANTIFICATION IN PATIENTS WITH SEPTIC SHOCK

ConditionSepsis and Septic Shock

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorInsel Gruppe AG, University Hospital Bern

About this trial

Sepsis-induced immunosuppression (SIS) is a common complication in patients with septic shock. Reduced expression of Human leukocyte antigen isotype DR (HLA-DR) on circulating monocytes is a marker for SIS and correlates with risk of secondary infections and mortality. The miRSep study aims to improve the understanding of early microRNA (miRNA) mediated changes in HLA-DR on monocytes in patients with septic shock.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

New onset (<24h) of septic shock diagnosis according to Sepsis-3 definition

(suspected) infection

Vasopressors required to maintain mean arterial pressure ≥65mm Hg (despite adequate fluid resuscitation)

Serum lactate level > 2mmol/L

Disqualifiers

Age < 18 years

Patients known not to speak German or French

Patients with known.

Pre-existing congenital or acquired severe immune deficiency (e.g. severe combined immunodeficiency, HIV infection, AIDS) or

Trial population

Patients receiving treatment in the ICU department of the University Hospital Bern, CH.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

56 Participants

are grouped into 2 trial groups

Group A: Septic shock

Group B: Critically ill patients

Trial outcomes

Primary outcomes

Difference in the miRNA-expression pattern in critically ill patients with/without sepsis-induced immunosuppression

Determine the early expression of specific miRNA candidates in monocytes of patients with sepsis induced immunosuppression compared to critically ill patients without sepsis induced immunosuppression using quantification by RT-qPCR

Time frame

3 Days following ICU admission

Secondary outcomes

Correlation between miRNA expression and sepsis outcome (30-day mortality)

Time frame

30 days following ICU admission

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Insel Gruppe AG, University Hospital Bern

Lead sponsor

Source ClinicalTrials.gov

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