Official Title
Sevoflurane Sedation in COVID-19 ARDS Patients to Reduce Lung Injury: a Randomized Controlled Trial
Brief Summary

The purpose of this trial is to study the effect of initial temporary sevoflurane sedation on mortality and persistent organ dysfunction (POD) in survivors at day 28 after ICU admission in the population of patients suffering from COVID-19 ARDS.

Detailed Description

The corona virus disease 19 (COVID-19) pandemic, caused by the severe acute respiratory
syndrome corona virus 2 (SARS-CoV-2), is spreading rapidly across Europe. While data from
European centers are still missing, several publications from Chinese centers are available.
Respiratory failure from acute respiratory distress syndrome (ARDS) is the leading cause of
mortality, and may be caused or exacerbated by a 'cytokine storm syndrome'.

Recent trials from our group demonstrated that the volatile anesthetic sevoflurane
administered during ventilation of patients has anti-inflammatory properties. Moreover, in in
vivo studies volatile anesthetics reduce the severity of ARDS compared to intravenous
sedation, which has been confirmed in a clinical pilot trial. Attenuating ARDS and thereby
improving oxygenation strongly decreases morbidity and mortality of patients.

Completed
ARDS, Human
Coronavirus

Drug: Sevoflurane

Sedation with sevoflurane (etSevo 0.5-1.5 Vol %) for 48 hours in patients with COVID-19 ARDS

Drug: Intravenous drug

Intravenous sedation in control group will be continued as initiated at the ICU e.g. propofol, fentanyl, midazolam, dexmedetomidine

Eligibility Criteria

Inclusion Criteria:

- SARS-CoV-2 infection (positive testing) or computed tomography (CT) scan-suspected
COVID-19 ARDS

- Male and female patients, age 18 to 85 years

- ICU patients with ARDS defined as PaO2/FiO2 < 200mmHg (=26.6kPa)

- Time of intubation not longer than 24 hours

- QTc Time (ECG) not longer than 470 ms ♂ (male)/ 480 ms ♀ (female)

- Sedation and mechanical ventilation in ICU

- Informed consent, signed by a representative or by an independent physician

Exclusion Criteria:

- High dose systemic corticosteroids in the phase before hospitalization (> 10mg/d
prednisone or equivalent dose)

- Significant concomitant disease (acute cerebral vascular event, acute coronary
syndrome, seizure, burn, neuromuscular disease)

- Organ transplant

- AIDS

- Pregnancy and/or breastfeeding

- Use of cytokine absorber

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 85 Years
Countries
Switzerland
Locations

Kantonsspital Münsterlingen
Münsterlingen, Switzerland

Cantonal Hospital of St. Gallen
Sankt Gallen, Switzerland

Stadtspital Triemli
Zurich, Switzerland

University Hospital Zuirch
Zurich, Switzerland

Beatrice Beck Schimmer, Prof, Study Chair
University of Zurich

University of Zurich
NCT Number
Keywords
Covid-19
ARDS
MeSH Terms
COVID-19
Respiratory Distress Syndrome
Sevoflurane