HFIP Ex-vivo Study

Impact of Hexafluoroisopropanol (HFIP) on the Inflammatory Response in Blood of Septic Patients (HFIP Ex-vivo Study). A Feasibility, Proof of Principle Project.

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis

• Study Type: Observational
• Enrollment (Anticipated): 36

Contacts and Locations

• Study Contact: Name: Beatrice Beck Schimmer, Prof. Dr. med; Phone Number: 0446355035; Email: beatrice.beckschimmer@uzh.ch

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Recruiting
    • University Hospital Zurich
    • Contact: Mattia M. Müller; Phone Number: 0446355035; Email: mattia.mueller@uzh.ch
    • Principal Investigator: Beatrice Beck Schimmer, Prof. Dr. med.
    • Sub-Investigator: Schläpfer Martin, PD Dr. med.
    • Sub-Investigator: Müller M. Mattia, Dr. med.
    • Sub-Investigator: Kern Sabine, study nurse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Beatrice Beck Schimmer, Prof. Dr. med., University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: August 15, 2019
• First Submitted That Met QC Criteria: August 15, 2019
• First Posted (Actual): August 16, 2019

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2019 - 00774

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No