Clinical trial NCT04059263: HFIP Ex-vivo Study
Official title: Impact of Hexafluoroisopropanol (HFIP) on the Inflammatory Response in Blood of Septic Patients (HFIP Ex-vivo Study). A Feasibility, Proof of Principle Project.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2019-08-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the emergency department of tertiary care hospital with suspicion of an infection and a qSOFA score ≥ 2 points.

Brief summary: Sepsis, a multi organ failure caused by infectious diseases, is a major health burden with an average mortality rate of 26%. Cells of the innate immune system of hosts recognize specific patterns of pathogenic bacteria and trigger an inflammatory response. In case of sepsis, this inflammatory response takes a deregulated course, expressing an overwhelming amount of pro-inflammatory cytokines leading to a loosening of endothelial tight junctions, evasion of intravasal fluids and proteins into the interstitium, as well as direct tissue damage throughout an overproduction of reactive oxygen species by neutrophils. These pathological changes of the host's proper immune system lead to a multi organ failure, which characterize a clinical pathomechanism of sepsis. Several studies confirmed an immunomodulatory effect of sevoflurane's primary metabolite hexafluoroisopropanol (HFIP) attenuating pro-inflammatory cytokine expression with a consecutive improvement of organ function and survival in rodent models of sepsis. Until now, there are no data available confirming this effect in septic patients as well. With this study, the direct impact of sevoflurane's primary metabolite HFIP on cytokine expression in the blood of septic patients will be investigated for the first time.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to the emergency ward with suspicion of infection and a qSOFA Score ≥ 2 points (Respiratory frequency \> 22/minute, Systolic blood pressure \< 100 mmHg, Glasgow Coma Scale \< 15).
* Male and Female subjects with at least 18 years of age.
* Written informed consent by the participant after information about the project. In emergency cases where a written consent cannot be obtained immediately, due to the patient's medical conditions, the existence of a patient decree and of a representative in the emergency situation is evaluated according to the Swiss Civil Code. Informed consent will be obtained from the representative. A medical doctor, furthermore, not participating in the investigation, guarantees the medical care of the patient by the defending of his/her interests. After recovery, the patient will be informed as soon as possible about the trial and consent is requested.

Exclusion Criteria:

* Acquired Immune Deficiency Syndrome
* Anti-IL-6 therapy (e.g. Kevzara®) within the last 60 days
* Application of a cytokine absorber
* Pregnancy and/or Breast feeding

Primary outcomes:
measure: Inflammatory response in blood of septic patients after application of HFIP
timeFrame: IL-6 will be measured after 6 hours incubation.
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Beatrice Beck Schimmer, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: