NCT04355962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2020

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

April 23, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2021

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2021

Completed
Last Updated

July 19, 2021

Status Verified

July 1, 2021

Enrollment Period

1.2 years

First QC Date

March 26, 2020

Last Update Submit

July 16, 2021

Conditions

ARDS, HumanCoronavirus

Keywords

COVID-19ARDS

Outcome Measures

Primary Outcomes (1)

  • Composite outcome of death rate (rate of patients that did not survive) and organ failure rate (rate of patients surviving with persistent organ dysfunction) at day 28

    The effect of sevoflurane application on mortality (rate of patients that does not survive 28 days) and persistent organ dysfunction (rate of patients surviving with a persistent organ failure at day 28) will be assessed. Organ failures are defined as pulmonary failure (necessity of ventilation); cardiovascular failure (need of vasopressors), retail failure (need of renal replacement therapy)

    28 days

Secondary Outcomes (4)

  • Length of stay ICU

    28 days

  • Plasma Inflammatory markers

    8 days

  • Length of stay at hospital

    28 days

  • Sex-related differences in complications

    28 days

Study Arms (2)

Sevoflurane Sedation

EXPERIMENTAL

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

Drug: Sevoflurane

Intravenous

ACTIVE COMPARATOR

No use of sevoflurane, but current intravenous sedation at discretion of the ICU physician in charge, e.g. with propofol, fentanyl, midazolam and dexmedetomidine

Drug: Intravenous drug

Interventions

SevofluraneDRUG

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

Sevoflurane Sedation
Intravenous drugDRUG

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

Intravenous

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kantonsspital Münsterlingen

Münsterlingen, 8596, Switzerland

Location

Cantonal Hospital of St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Stadtspital Triemli

Zurich, 8063, Switzerland

Location

University Hospital Zuirch

Zurich, 8091, Switzerland

Location

Related Publications (6)

  • Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

    PMID: 32091533BACKGROUND

  • Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.

    PMID: 32031570BACKGROUND

  • Xie J, Tong Z, Guan X, Du B, Qiu H, Slutsky AS. Critical care crisis and some recommendations during the COVID-19 epidemic in China. Intensive Care Med. 2020 May;46(5):837-840. doi: 10.1007/s00134-020-05979-7. Epub 2020 Mar 2. No abstract available.

    PMID: 32123994BACKGROUND

  • Suter D, Spahn DR, Blumenthal S, Reyes L, Booy C, Z'graggen BR, Beck-Schimmer B. The immunomodulatory effect of sevoflurane in endotoxin-injured alveolar epithelial cells. Anesth Analg. 2007 Mar;104(3):638-45. doi: 10.1213/01.ane.0000255046.06058.58.

    PMID: 17312223BACKGROUND

  • Yue T, Roth Z'graggen B, Blumenthal S, Neff SB, Reyes L, Booy C, Steurer M, Spahn DR, Neff TA, Schmid ER, Beck-Schimmer B. Postconditioning with a volatile anaesthetic in alveolar epithelial cells in vitro. Eur Respir J. 2008 Jan;31(1):118-25. doi: 10.1183/09031936.00046307. Epub 2007 Sep 26.

    PMID: 17898018BACKGROUND

  • Beck-Schimmer B, Schadde E, Pietsch U, Filipovic M, Dubendorfer-Dalbert S, Fodor P, Hubner T, Schuepbach R, Steiger P, David S, Kruger BD, Neff TA, Schlapfer M. Early sevoflurane sedation in severe COVID-19-related lung injury patients. A pilot randomized controlled trial. Ann Intensive Care. 2024 Mar 27;14(1):41. doi: 10.1186/s13613-024-01276-4.

    PMID: 38536545DERIVED

MeSH Terms

Conditions

Respiratory Distress SyndromeCoronavirus InfectionsCOVID-19

Interventions

SevofluraneInfusion Pumps

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract Infections

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsEquipment and SuppliesArtificial OrgansSurgical Equipment

Study Officials

  • Beatrice Beck Schimmer, Prof

    University of Zurich

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Patients will not be informed about their group assignments, technicians processing the samples will not have any access to the ICU or the patient chart (= double-blind trial). Due to the procedures involved in volatile versus intravenous sedation, group assignment cannot be entirely concealed for the study staff and ICU doctors/nurses involved with the procedure in the ICU (pragmatic limits of blinding).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: a randomized, controlled multi-center trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2020

First Posted

April 21, 2020

Study Start

April 23, 2020

Primary Completion

June 25, 2021

Study Completion

July 16, 2021

Last Updated

July 19, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

CH(4)