SepsisNCT04059263
HFIP Ex-vivo Study
An observational study of Sepsis, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Aug 2019to 26 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the emergency department of tertiary care hospital with suspicion of an infection and a qSOFA score ≥ 2 points.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
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
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: IL-6 will be measured after 6 hours incubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start5 Aug 2019
- Primary completion26 Jun 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beatrice Beck Schimmer, Prof. Dr. med., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059263
- Sponsor's protocol ID
- 2019 - 00774
- Other IDs
- 2019
- Status last verified
- Jul 2024
- First submitted
- 15 Aug 2019
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04059263
- Acronym / sponsor ID
- 2019 - 00774
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 16 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the emergency department of tertiary care hospital with suspicion of an infection and a qSOFA score ≥ 2 points.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inflammatory response in blood of septic patients after application of HFIP
Time frame: IL-6 will be measured after 6 hours incubation.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatrice Beck Schimmer, Prof. Dr. med. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory response in blood of septic patients after application of HFIP (time frame: IL-6 will be measured after 6 hours incubation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.