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Sevoflurane Sedation in Patients With Septic Shock

ConditionShock, Septic
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Zurich

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sevoflurane

    Drug

    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

    Drug

    Included patients randomized in control group, intravenouse sedation is continued with propofol

Treatment groups

153 Participants
are divided into 2 treatment groups
Group A: Sevoflurane SedationExperimental treatment 1 intervention
Group B: Propofol SedationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Concentration of interleukin-6 over time

To see if the interleukin-6 decreases under the influence of sevoflurane

Time frame
5 days

Secondary outcomes

1

Pro-/anti-inflammatory mediators

effect on inflammatory/anti- inflammatory mediators

Time frame
5 days
2

Vasopressor support

Use of vasopressor support (norepinephrine, dobutamine, vasopressin) will be determined.

Time frame
5 days
3

Sequential organ failure score (SOFA Score)

Sepsis related organ failure score

Time frame
5 days
4

Richmond Agitation Sedation Scale

A scale to measure the agitation or sedation level of a patient

Time frame
5 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Zurich

Lead sponsor

Kantonsspital Münsterlingen

Collaborator

Triemli Hospital

Collaborator

Waid City Hospital, Zurich

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: