MIRNA QUANTIFICATION IN PATIENTS WITH SEPTIC SHOCK

MIRSEP - MIRNA QUANTIFICATION IN PATIENTS WITH SEPTIC SHOCK

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07597122

Acronym

MIRSEP

Enrollment

Registered

2026-05-19

Start date

2026-06-01

Completion date

2027-12-31

Last updated

2026-06-02

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

Conditions

Sepsis and Septic Shock

Keywords

Septic shock, Sepsis induced immunusuppression, HLA-DR, miRNA, Monocytes

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Septic shock: * 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 * Minimum age of 18 years * Expected length of stay \>48h * Written consent from an independent physician Critically ill: * Patients on mechanical ventilation (MV) in the ICU without an admission diagnosis of sepsis/septic shock according to Sepsis-3 definition * Minimum age of 18 years * Expected length of stay \>48h * Written consent from an independent physician

Exclusion criteria

* Age \< 18 years * Patients known not to speak German or French * Patients with known. 1. Pre-existing congenital or acquired severe immune deficiency (e.g. severe combined immunodeficiency, HIV infection, AIDS) or 2. current immunosuppressive therapy (immunosuppressive biologicals or active lymphocyte therapy e.g. endoxan, rituximab or corticosteroid use at a dose \> 10 mg/day equivalent of prednisone. However, acute corticosteroid treatment of a relative adrenal insufficiency using a maximum hydrocortisone dose of 200 mg/day is accepted.

Design outcomes

Primary

Measure	Time frame	Description
Difference in the miRNA-expression pattern in critically ill patients with/without sepsis-induced immunosuppression	3 Days following ICU admission	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

Secondary

Measure	Time frame
Correlation between miRNA expression and sepsis outcome (30-day mortality)	30 days following ICU admission

Countries

Switzerland

Outcome results