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NCT Number: NCT07597122

MIRNA QUANTIFICATION IN PATIENTS WITH SEPTIC SHOCK

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.

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Key information

Conditions

Sepsis and Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 30 days following ICU admission

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

MIRSEP - MIRNA QUANTIFICATION IN PATIENTS WITH SEPTIC SHOCK

Acronym: MIRSEP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 19, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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