NCT07597122 MIRNA QUANTIFICATION IN PATIENTS WITH SEPTIC SHOCK
| NCT ID | NCT07597122 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Sepsis and Septic Shock |
| Study Type | OBSERVATIONAL |
| Enrollment | 56 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 56 participants in total. It began in 2026-06-01 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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. 1. Pre-existing congenital or acquired severe immune deficiency (e.g. severe combined immunodeficiency, HIV infection, AIDS) or 2. 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.
Frequently Asked Questions
Who can join the NCT07597122 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sepsis and Septic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07597122 currently recruiting?
Yes, NCT07597122 is actively recruiting participants. Visit ClinicalTrials.gov or contact Insel Gruppe AG, University Hospital Bern to inquire about joining.
Where is the NCT07597122 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT07597122 clinical trial?
NCT07597122 is sponsored by Insel Gruppe AG, University Hospital Bern. The trial plans to enroll 56 participants.