Sepsis and Septic ShockMIRSEPNCT07597122
MIRNA QUANTIFICATION IN PATIENTS WITH SEPTIC SHOCK
An observational study of Sepsis and Septic Shock, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis and Septic Shock
- How many people
- 56 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving treatment in the ICU department of the University Hospital Bern, CH.
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital
Bern, 3010
Joerg C Schefold, Prof. Dr. med, 0041 31 632 39 16, joerg.schefold@insel.ch
About this study
Official title: MIRSEP - 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.
- Conditions
- Sepsis and Septic Shock
- Keywords
- Septic shock, Sepsis induced immunusuppression, HLA-DR, miRNA, Monocytes
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Septic shock | Patients in ICU with diagnosed septic shock | |
| Critically ill patients | Critically ill patients in ICU without sepsis diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 Days following ICU admission
Secondary outcomes (1)
Correlation between miRNA expression and sepsis outcome (30-day mortality)
Measured: 30 days following ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Jun 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis and Septic ShockStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597122
- Sponsor's protocol ID
- 2026-00370
- Acronym
- MIRSEP
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIRSEP - MIRNA QUANTIFICATION IN PATIENTS WITH SEPTIC SHOCK
- ClinicalTrials.gov ID
- NCT07597122
- Acronym / sponsor ID
- MIRSEP / 2026-00370
- Conditions
- Sepsis and Septic Shock
- Keywords
- Septic shock, Sepsis induced immunusuppression, HLA-DR, miRNA, Monocytes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Septic shock | – | –Patients in ICU with diagnosed septic shock |
| Critically ill patients | – | –Critically ill patients in ICU without sepsis diagnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving treatment in the ICU department of the University Hospital Bern, CH.
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (5 listed)
- Age < 18 years
- Patients known not to speak German or French
- Patients with known.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Correlation between miRNA expression and sepsis outcome (30-day mortality)
Time frame: 30 days following ICU admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the miRNA-expression pattern in critically ill patients with/without sepsis-induced immunosuppression (time frame: 3 Days following ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.