HFIP Ex-vivo Study

Sepsis Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04059263
• Other study ID #: 2019 - 00774
• Status: Recruiting
• Start date: August 5, 2019
• Est. completion date: March 1, 2025

Study information

• Verified date: June 2024
• Source: University of Zurich
• Contact: Beatrice Beck Schimmer, Prof. Dr. med
• Phone: 0446355035
• Email: beatrice.beckschimmer[@]uzh.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: March 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory response in blood of septic patients after application of HFIP	Interleukine-6 (IL-6) will be measured with Enzyme-linked Immunosorbent Sandwich Assay as a surrogate marker of inflammatory response. Amount of IL-6 is compared between treated samples and control samples.	IL-6 will be measured after 6 hours incubation.