Actively Recruiting
MIRSEP - miRNA Quantification in Patients With Septic Shock
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2026-06-02
56
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Sepsis-induced immunosuppression (SIS) is a frequent complication in patients experiencing septic shock. This condition is marked by reduced expression of Human leukocyte antigen isotype DR (HLA-DR) on circulating monocytes, which is linked to a higher risk of secondary infections and death. The miRSep study aims to better understand how early microRNA (miRNA) changes affect HLA-DR expression in these patients with septic shock. The study is observational and involves two groups: patients in the ICU diagnosed with septic shock and critically ill ICU patients without sepsis. Participants will be observed to compare miRNA expression patterns between those with or without sepsis-induced immunosuppression. The primary outcome is measured three days after ICU admission, focusing on differences in miRNA expression. Secondary outcomes include the relationship between miRNA levels and sepsis outcomes, such as 30-day mortality. Participants will be adults admitted to the ICU and expected to stay more than 48 hours. Researchers will collect data within the first few days of ICU admission, including laboratory assessments related to miRNA and immune markers. The study tracks outcomes for up to 30 days following admission to better understand the role of miRNA in septic shock. Participation involves monitoring and data collection without interventional treatments, and the study is expected to complete by the end of 2027.
CONDITIONS
Brief Title
MIRNA QUANTIFICATION IN PATIENTS WITH SEPTIC SHOCK
Who Can Participate
Eligibility Criteria
You may qualify if you...
- New onset (less than 24 hours) of septic shock diagnosis according to Sepsis-3 definition
- Suspected infection
- Vasopressors required to maintain mean arterial pressure of at least 65 mm Hg despite adequate fluid resuscitation
- Serum lactate level greater than 2 mmol/L
- Minimum age of 18 years
- Expected length of stay in ICU more than 48 hours
- Written consent from an independent physician
- Patients on mechanical ventilation in ICU without sepsis/septic shock diagnosis
- Minimum age of 18 years
- Expected length of stay in ICU more than 48 hours
- Written consent from an independent physician
You will not qualify if you...
- Age less than 18 years
- Patients known not to speak German or French
- Pre-existing severe immune deficiency (e.g., severe combined immunodeficiency, HIV infection, AIDS)
- Current immunosuppressive therapy (biologicals or active lymphocyte therapy such as endoxan, rituximab, or corticosteroids above 10 mg/day prednisone equivalent)
- Acute corticosteroid treatment for adrenal insufficiency with hydrocortisone dose up to 200 mg/day is allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days following ICU admission
Participants in intensive care units are assessed for miRNA expression patterns related to septic shock or critical illness.
1 to 2 visits depending on clinical status
Duration - 30 days following ICU admission
Participants are observed for outcomes including 30-day mortality and correlation with miRNA expression.
Follow-up observations during ICU stay and up to 30 days
Trial Site Locations
Total: 1 location
1
Inselspital
Bern, Switzerland, 3010
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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