Sevoflurane Sedation in Patients with Septic Shock (SSiS)

March 26, 2025 updated by: University of Zurich

Sevoflurane Sedation: a Potentially Promising Immunomodulation in Patients with Septic Shock

Recent in vivo studies from others as well as the investigators group demonstrated that volatile anesthetics immunomodulate sepsis and improve outcome. Also, several clinical trials have convincingly shown that application of a volatile anesthetic provides protection in patients undergoing major surgery.

Patients with sepsis are intubated and ventilated and therefore need sedation. So far, most ICU centers use intravenously applied sedatives in these patients. In the proposed study, we will switch sedation from an intravenous to a volatile anesthetic for a short period of time to explore if sepsis markers improve within the following 120 hours upon sevoflurane conditioning.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled trial (RCT) will be conducted over a period of 48 months, to investigate if volatile anesthetics have a positive effect on the prognostic sepsis marker IL-6. All patients with septic shock are intubated, ventilated and sedated with an intravenous anesthetic. In this study, eligible patients diagnosed with septic shock will be randomized 1:1 to the 'volatile group' with interruption of the propofol infusion, followed by a 4-hour sedation with the volatile anesthetic sevoflurane, or a continuous intravenous sedation ('intravenous' =control group). In both groups, 'intravenous' and 'volatile', the inflammatory markers as well as clinical parameters will be determined. The investigators will explore if there is a difference between the course of sepsis markers of the two groups within 5 days after intervention in favor of the volatile group.

Study Type

Interventional

Enrollment (Estimated)

153

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and female patients, age 18 to 80 years
  • Intensive care Unit (ICU) patients with septic shock (despite fluid resuscitation vasopressors needed to maintain mean arterial pressure ≥65 millimeter of mercury (mmHg), and serum lactate >2mmol/l even with fluid application)
  • Treatment of septic shock on ICU with vasopressors not longer than 12 hours
  • Sedation and mechanical ventilation on ICU
  • Female patients of childbearing potential with negative pregnancy test
  • Informed Consent as documented by signature

Exclusion Criteria:

  • Previous surgery and/or anesthesia (within last 7 days)
  • Application of nitric oxide (NO)
  • Suspected or known intolerance by history to volatile anesthetics (malignant hyperthermia)
  • Immunosuppressive agents
  • Systemic corticosteroids in the phase before hospitalization (> 10mg/d prednisone)
  • Significant concomitant disease (acute cerebral vascular event, acute coronary syndrome, decompensated heart failure, acute pulmonary edema, major cardiac arrhythmia, seizure, burn, chronic kidney disease, end stage liver failure, neuromuscular disease)
  • AIDS
  • Autoimmune disease
  • Organ transplant
  • Subject with active malignancy receiving
  • chemotherapy or radiation treatment within last 60 days
  • Hepatitis B/C virus infection
  • Anti-tumor necrosis factor (TNF) therapy
  • Pregnancy and/or Breast feeding
  • Use of cytokine absorber
  • Enrollment in any other clinical trial during the course of this trial, 30 days prior to its beginning or 30 days after its completion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sevoflurane Sedation
Patients randomized into experimental group will be treated with sevoflurane during 4 hours
Drug: Sevoflurane
Included patients, randomized in experimental group, intravenous sedation will be interrupted and followed by a 4 hour sedation with the volatile anesthetic sevoflurane.
Active Comparator: Propofol Sedation
Patients randomized into Control Group will get continued intravenous sedation with propofol
Drug: Control Group
Included patients randomized in control group, intravenouse sedation is continued with propofol
Other Names:
  • Propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of interleukin-6 over time
Time Frame: 5 days
To see if the interleukin-6 decreases under the influence of sevoflurane
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pro-/anti-inflammatory mediators
Time Frame: 5 days
effect on inflammatory/anti- inflammatory mediators
5 days
Vasopressor support
Time Frame: 5 days
Use of vasopressor support (norepinephrine, dobutamine, vasopressin) will be determined.
5 days
Sequential organ failure score (SOFA Score)
Time Frame: 5 days
Sepsis related organ failure score
5 days
Richmond Agitation Sedation Scale
Time Frame: 5 days
A scale to measure the agitation or sedation level of a patient
5 days
Duration of mechanical ventilation
Time Frame: 28 days
Time of mechanical ventilation
28 days
Mortality
Time Frame: 28 days
Mortality information in intensive care unit and on the ward
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

Triemli Hospital
Kantonsspital Münsterlingen
Waid City Hospital, Zurich

Investigators

  • Principal Investigator: Martin Schlaepfer, PD, University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

June 20, 2017

First Submitted That Met QC Criteria

August 21, 2018

First Posted (Actual)

August 22, 2018

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 26, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSiS

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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