RecruitingNCT07597122

MIRNA QUANTIFICATION IN PATIENTS WITH SEPTIC SHOCK

MIRSEP - MIRNA QUANTIFICATION IN PATIENTS WITH SEPTIC SHOCK


Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

56 participants

Start Date

Jun 1, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria13

  • 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 Criteria5

  • 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.

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Locations(1)

Inselspital

Bern, Switzerland

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NCT07597122


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