Sevoflurane Sedation in Patients With Septic Shock

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.

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