MIRNA QUANTIFICATION IN PATIENTS WITH SEPTIC SHOCK

NCT07597122 | Not Yet Recruiting

• 1 other identifier: 2026-00370
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis and Septic Shock

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  3 Days following ICU admission

Secondary Outcomes (1)

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

  30 days following ICU admission

Study Arms (2)

Septic shock

Patients in ICU with diagnosed septic shock

Critically ill patients

Critically ill patients in ICU without sepsis diagnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

CH (1)