HFIP Ex-vivo Study

NCT04059263 | Completed

• 1 other identifier: 2019 - 00774
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Beatrice Beck Schimmer, Prof. Dr. med.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 16, 2019
• Study Start: August 5, 2019
• Primary Completion: June 26, 2024
• Study Completion: June 26, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)