MIRNA QUANTIFICATION IN PATIENTS WITH SEPTIC SHOCK
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sepsis and Septic Shock. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
MIRSEP - MIRNA QUANTIFICATION IN PATIENTS WITH SEPTIC SHOCK
Overview
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.
Primary outcome measures
- Difference in the miRNA-expression pattern in critically ill patients with/without sepsis-induced immunosuppression [Time frame: 3 Days following ICU admission]
Secondary outcome measures (1)
- Correlation between miRNA expression and sepsis outcome (30-day mortality) [Time frame: 30 days following ICU admission]
Eligibility criteria
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.
- Pre-existing congenital or acquired severe immune deficiency (e.g. severe combined immunodeficiency, HIV infection, AIDS) or
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- Inselspital — Bern
Identifiers
NCT: NCT07597122 · 2026-00370