An interventional study of Treatment protocol with adsorption in Endocarditis, Sepsis and Septic Shock, sponsored by Insel Gruppe AG, University Hospital Bern. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-12.
Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Treatment
Infectious endocarditis (IE) and other severe infections are well-known to induce significant changes in the immune response including immune functionality in a considerable number of affected patients. In fact, numerous patients with IE develop a persistent functional immunological phenotype that can best be characterized by a profound anti-inflammation and/or functional anergy. This was previously referred to as "injury-associated immunosuppression (IAI)" by Pfortmüller et al., published in Intensive Care Medicine Experimental 2017. IAI can be assessed by measurement of cellular (functional) markers. Persistence of IAI is associated with prolonged ICU length of stay, increased secondary infection rates, and death. Immunomodulation to reverse IAI was shown beneficial in immunostimulatory (randomized controlled) clinical trials. CytoSorb® treatment is currently used as standard of care in some institutions in surgically treated IE patients. The investigators aim to investigate two accepted treatment protocols and aim to explore whether adsorption with a cytokine adsorption filter can increase immune competence in treated individuals.
173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.
This study's planned enrollment of 54 is below the median of 92 across 86 interventional studies indexed under Endocarditis.
Browse Endocarditis studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 741 studies on the registry; 180 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Treatment protocol with adsorption
Adsorption while patients are in the OR on the extracorporeal circuit
Change in quantitative expression of monocytic Human Leukocyte Antigen (mHLA)-DR expression (Antibodies per cell on Cluster of Differentiation (CD)14+ monocytes/macrophages, assessed using a quantitative standardized assay)
Time frame: From baseline (pre-OR, t1) to day 1 post-OR (t3)
Change in mHLA-DR from baseline (pre-OR) to post-Or and 3 days post-Or.
Course of mHLA-DR
Time frame: Baseline (pre-OP) to post-OR and 3 days post-Or
Area under the curve of quantitative mHLA-DR expression
Area under the curves mHLA-DR
Time frame: Between baseline (pre-OR), post-OR, and day 1 and 3 post-OR (multiple assessments).
Change in inflammatory markers including cytokines (Interleukin (IL)-6, IL-10, C-reactive protein, White blood cell count, multiplex Enzyme linked immunosorbent assay, and inflammatory prohormones)
Change in inflammatory parameters
Time frame: From baseline (pre-OR) to post-OR, and day 1 and 3 post-OR
Change in organ dysfunction (Sepsis-related organ failure (SOFA) scores incl. subscores and Simplified acute physiology score (SAPS II scores) daily
Course of organ dysfunction
Time frame: 7-day timeframe (starting from ICu admission, assessed at day 90)
Length of ICU and hospital stay (days after surgical intervention).
Length of stay
Time frame: Number of days on ICU and in hospital (assessed at day 90)
Cumulative Therapeutic Intervention Scoring System (TISS) points (resource need) until ICU-discharge
Resource use
Time frame: Total number of TISS points on ICU (cumulative), assessed at day 90
Total amount of infused volume/transfusions on ICU
Need for fluid therapy
Time frame: 90 days
Duration of vasoactive drug therapy
Vasopressor use
Time frame: 90 days
Duration of invasive mechanical ventilation
Use of organ support therapy (number of days on mechanical ventilation)
Time frame: 90 days
ICU mortality rate
Number of non-surviving patients in both study groups
Time frame: ICU stay (assessed at day 90)
Hospital mortality rate
Number of non-surviving patients in both study groups
Time frame: hospital stay (assessed at day 90)
28 day mortality rate
Number of non-surviving patients in both study groups
Time frame: 28 days beginning from ICU admission (assessed at day 90)
90 day mortality rate
Number of non-surviving patients in both study groups
Time frame: 90 days beginning from ICU admission (assessed at day 90)
Duration of renal replacement therapy
Use of organ support therapy (number of days on renal replacement therapy)
Time frame: 90 days
Plan to share: No
Ran from Nov 2019 to primary completion in Nov 2024, 59 months.
Of 34 interventional studies with no phase under Endocarditis, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 59. This study's 59 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Insel Gruppe AG, University Hospital Bern →