Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
153 participants
INTERVENTIONAL
2026-01-31
2027-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sevoflurane Sedation
Patients randomized into experimental group will be treated with sevoflurane during 4 hours
Sevoflurane
Included patients, randomized in experimental group, intravenous sedation will be interrupted and followed by a 4 hour sedation with the volatile anesthetic sevoflurane.
Propofol Sedation
Patients randomized into Control Group will get continued intravenous sedation with propofol
Control Group
Included patients randomized in control group, intravenouse sedation is continued with propofol
Interventions
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Sevoflurane
Included patients, randomized in experimental group, intravenous sedation will be interrupted and followed by a 4 hour sedation with the volatile anesthetic sevoflurane.
Control Group
Included patients randomized in control group, intravenouse sedation is continued with propofol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Kantonsspital Münsterlingen
OTHER
Triemli Hospital
OTHER
Waid City Hospital, Zurich
OTHER
University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Martin Schlaepfer, PD
Role: PRINCIPAL_INVESTIGATOR
University of Zurich
Locations
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Kantonasspital Münsterlingen
Münsterlingen, , Switzerland
Stadtspital Triemli
Zurich, , Switzerland
University Hospital of Zurich
Zurich, , Switzerland
Waidspital Zürich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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Tang BM, McLean AS, Dawes IW, Huang SJ, Lin RC. The use of gene-expression profiling to identify candidate genes in human sepsis. Am J Respir Crit Care Med. 2007 Oct 1;176(7):676-84. doi: 10.1164/rccm.200612-1819OC. Epub 2007 Jun 15.
Lu Y, Wang J, Yan J, Yang Y, Sun Y, Huang Y, Hu R, Zhang Y, Jiang H. Sevoflurane attenuate hypoxia-induced VEGF level in tongue squamous cell carcinoma cell by upregulating the DNA methylation states of the promoter region. Biomed Pharmacother. 2015 Apr;71:139-45. doi: 10.1016/j.biopha.2015.02.032. Epub 2015 Mar 3.
Klag T, Cantara G, Sechtem U, Athanasiadis A. Interleukin-6 Kinetics can be Useful for Early Treatment Monitoring of Severe Bacterial Sepsis and Septic Shock. Infect Dis Rep. 2016 Mar 21;8(1):6213. doi: 10.4081/idr.2016.6213. eCollection 2016 Mar 21.
Rios-Toro JJ, Marquez-Coello M, Garcia-Alvarez JM, Martin-Aspas A, Rivera-Fernandez R, Saez de Benito A, Giron-Gonzalez JA. Soluble membrane receptors, interleukin 6, procalcitonin and C reactive protein as prognostic markers in patients with severe sepsis and septic shock. PLoS One. 2017 Apr 5;12(4):e0175254. doi: 10.1371/journal.pone.0175254. eCollection 2017.
Tschaikowsky K, Hedwig-Geissing M, Braun GG, Radespiel-Troeger M. Predictive value of procalcitonin, interleukin-6, and C-reactive protein for survival in postoperative patients with severe sepsis. J Crit Care. 2011 Feb;26(1):54-64. doi: 10.1016/j.jcrc.2010.04.011. Epub 2010 Jun 19.
Gordon AC, Mason AJ, Thirunavukkarasu N, Perkins GD, Cecconi M, Cepkova M, Pogson DG, Aya HD, Anjum A, Frazier GJ, Santhakumaran S, Ashby D, Brett SJ; VANISH Investigators. Effect of Early Vasopressin vs Norepinephrine on Kidney Failure in Patients With Septic Shock: The VANISH Randomized Clinical Trial. JAMA. 2016 Aug 2;316(5):509-18. doi: 10.1001/jama.2016.10485.
Fleischmann C, Scherag A, Adhikari NK, Hartog CS, Tsaganos T, Schlattmann P, Angus DC, Reinhart K; International Forum of Acute Care Trialists. Assessment of Global Incidence and Mortality of Hospital-treated Sepsis. Current Estimates and Limitations. Am J Respir Crit Care Med. 2016 Feb 1;193(3):259-72. doi: 10.1164/rccm.201504-0781OC.
Kellner P, Muller M, Piegeler T, Eugster P, Booy C, Schlapfer M, Beck-Schimmer B. Sevoflurane Abolishes Oxygenation Impairment in a Long-Term Rat Model of Acute Lung Injury. Anesth Analg. 2017 Jan;124(1):194-203. doi: 10.1213/ANE.0000000000001530.
Other Identifiers
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SSiS
Identifier Type: -
Identifier Source: org_study_id
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