AnaConDa-therapy in COVID-19 Patients

NCT05586126 | Terminated

• 1 other identifier: 2020.10.15.03
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

COVID 19-pneumonia may evolve into respiratory insufficiency for which invasive mechanical ventilation is required. Recently, inhaled anesthetics have become available for sedation of critically ill patients. Based upon recent research, these anesthetics may provide advantages in improvement of P/F ratio in ARDS patients. However, up to now, its effects on COVID-19 pneumonia patients is unknown; therefore, this study was designed as a plan to investigate whether the use of inhaled sevoflurane leads to improvement of oxygenation compared to intravenous sedatives in mechanically ventilated COVID-19 patients

Conditions

COVID-19; SARS CoV-2

Keywords

sevoflurane; propofol; midazolam; COVID-19

Outcome Measures

Primary Outcomes (1)

• P/F ratio

  arterial oxygen tension divided by fraction of inspired oxygen

  day 2 after intubation

Secondary Outcomes (6)

• duration of ICU admission

  through ICU admission

• 28VFD

  28 days after intubation

• 28DFD

  28 days after intubation

• need for vasopressors

  duration of ICU stay

• 28DM

  28 days after intubation

Study Arms (2)

Sevoflurane

patients admitted because of respiratory insufficiency due to COVID-19 with need for invasive mechanical ventilation that are sedated by using sevoflurane

Drug: Sevoflurane

Control

patients admitted because of respiratory insufficiency due to COVID-19 with need for invasive mechanical ventilation that are sedated by means of intravenous medication, such as propofol, midazolam, esketamine of fentanyl

Interventions

Sevoflurane DRUG

sevoflurane inhalation

Sevoflurane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with proven COVID-19 and need for invasive mechanical ventilation in the ICU of the Jeroen Bosch Hospital

You may qualify if:

• Age \>18 years
• More than 24 hours of invasive mechanical ventilation needed
• Positive test (e.g. Polymerase Chain Reaction (PCR)) for SARS-CoV-2

You may not qualify if:

• pulmonary history
• known allergy or hypersensitivity for halogenated anesthetics
• known or suspected predisposition for malignant hyperthermia
• suspected or proven intracranial hypertension
• severe liver dysfunction and/or icterus (serum bilirubin \>42,8-51,3 μg per liter)
• neutropenia (\<0.5X10\^9 neutrophils per liter)
• chemotherapy in the month prior to ICU admission
• patients that are transported to other hospitals during admission

Sponsors & Collaborators

• Jeroen Bosch Ziekenhuis: lead

Study Sites (1)

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, North Brabant, 5200 ME, Netherlands

Location

Related Publications (17)

• Banks WA, Kastin AJ, Gutierrez EG. Penetration of interleukin-6 across the murine blood-brain barrier. Neurosci Lett. 1994 Sep 26;179(1-2):53-6. doi: 10.1016/0304-3940(94)90933-4.

  PMID: 7845624 BACKGROUND

• Bernard GR, Artigas A, Brigham KL, Carlet J, Falke K, Hudson L, Lamy M, LeGall JR, Morris A, Spragg R. Report of the American-European consensus conference on ARDS: definitions, mechanisms, relevant outcomes and clinical trial coordination. The Consensus Committee. Intensive Care Med. 1994;20(3):225-32. doi: 10.1007/BF01704707.

  PMID: 8014293 BACKGROUND

• Bisbal M, Arnal JM, Passelac A, Sallee M, Demory D, Donati SY, Granier I, Corno G, Durand-Gasselin J. [Efficacy, safety and cost of sedation with sevoflurane in intensive care unit]. Ann Fr Anesth Reanim. 2011 Apr;30(4):335-41. doi: 10.1016/j.annfar.2011.01.019. Epub 2011 Mar 15. French.

  PMID: 21411266 BACKGROUND

• Burki T. The origin of SARS-CoV-2. Lancet Infect Dis. 2020 Sep;20(9):1018-1019. doi: 10.1016/S1473-3099(20)30641-1. No abstract available.

  PMID: 32860762 BACKGROUND

• Ferrando C, Aguilar G, Piqueras L, Soro M, Moreno J, Belda FJ. Sevoflurane, but not propofol, reduces the lung inflammatory response and improves oxygenation in an acute respiratory distress syndrome model: a randomised laboratory study. Eur J Anaesthesiol. 2013 Aug;30(8):455-63. doi: 10.1097/EJA.0b013e32835f0aa5.

  PMID: 23545542 BACKGROUND

• Gattinoni L, Chiumello D, Caironi P, Busana M, Romitti F, Brazzi L, Camporota L. COVID-19 pneumonia: different respiratory treatments for different phenotypes? Intensive Care Med. 2020 Jun;46(6):1099-1102. doi: 10.1007/s00134-020-06033-2. Epub 2020 Apr 14. No abstract available.

  PMID: 32291463 BACKGROUND

• Grifoni E, Valoriani A, Cei F, Lamanna R, Gelli AMG, Ciambotti B, Vannucchi V, Moroni F, Pelagatti L, Tarquini R, Landini G, Vanni S, Masotti L. Interleukin-6 as prognosticator in patients with COVID-19. J Infect. 2020 Sep;81(3):452-482. doi: 10.1016/j.jinf.2020.06.008. Epub 2020 Jun 8. No abstract available.

  PMID: 32526326 BACKGROUND

• Jabaudon M, Boucher P, Imhoff E, Chabanne R, Faure JS, Roszyk L, Thibault S, Blondonnet R, Clairefond G, Guerin R, Perbet S, Cayot S, Godet T, Pereira B, Sapin V, Bazin JE, Futier E, Constantin JM. Sevoflurane for Sedation in Acute Respiratory Distress Syndrome. A Randomized Controlled Pilot Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):792-800. doi: 10.1164/rccm.201604-0686OC.

  PMID: 27611637 BACKGROUND

• Jerath A, Ferguson ND, Cuthbertson B. Inhalational volatile-based sedation for COVID-19 pneumonia and ARDS. Intensive Care Med. 2020 Aug;46(8):1563-1566. doi: 10.1007/s00134-020-06154-8. Epub 2020 Jun 25.

  PMID: 32588067 BACKGROUND

• Jerath A, Parotto M, Wasowicz M, Ferguson ND. Volatile Anesthetics. Is a New Player Emerging in Critical Care Sedation? Am J Respir Crit Care Med. 2016 Jun 1;193(11):1202-12. doi: 10.1164/rccm.201512-2435CP.

  PMID: 27002466 BACKGROUND

• 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.

  PMID: 27782948 BACKGROUND

• Mesnil M, Capdevila X, Bringuier S, Trine PO, Falquet Y, Charbit J, Roustan JP, Chanques G, Jaber S. Long-term sedation in intensive care unit: a randomized comparison between inhaled sevoflurane and intravenous propofol or midazolam. Intensive Care Med. 2011 Jun;37(6):933-41. doi: 10.1007/s00134-011-2187-3. Epub 2011 Mar 29.

  PMID: 21445642 BACKGROUND

• O'Gara B, Talmor D. Lung protective properties of the volatile anesthetics. Intensive Care Med. 2016 Sep;42(9):1487-9. doi: 10.1007/s00134-016-4429-x. Epub 2016 Jul 4. No abstract available.

  PMID: 27376746 BACKGROUND

• Perbet S, Bourdeaux D, Sautou V, Pereira B, Chabanne R, Constantin JM, Chopineau J, Bazin JE. A pharmacokinetic study of 48-hour sevoflurane inhalation using a disposable delivery system (AnaConDa(R)) in ICU patients. Minerva Anestesiol. 2014 Jun;80(6):655-65. Epub 2013 Nov 13.

  PMID: 24226486 BACKGROUND

• Soukup J, Selle A, Wienke A, Steighardt J, Wagner NM, Kellner P. Efficiency and safety of inhalative sedation with sevoflurane in comparison to an intravenous sedation concept with propofol in intensive care patients: study protocol for a randomized controlled trial. Trials. 2012 Aug 10;13:135. doi: 10.1186/1745-6215-13-135.

  PMID: 22883020 BACKGROUND

• Strosing KM, Faller S, Gyllenram V, Engelstaedter H, Buerkle H, Spassov S, Hoetzel A. Inhaled Anesthetics Exert Different Protective Properties in a Mouse Model of Ventilator-Induced Lung Injury. Anesth Analg. 2016 Jul;123(1):143-51. doi: 10.1213/ANE.0000000000001296.

  PMID: 27023766 BACKGROUND

• Ware LB, Matthay MA. Alveolar fluid clearance is impaired in the majority of patients with acute lung injury and the acute respiratory distress syndrome. Am J Respir Crit Care Med. 2001 May;163(6):1376-83. doi: 10.1164/ajrccm.163.6.2004035.

  PMID: 11371404 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

COVID-19

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• D. van Nieuwenhuizen, RN

  Jeroen Bosch Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: October 19, 2022
• Study Start: October 1, 2020
• Primary Completion: January 27, 2021
• Study Completion: July 1, 2022
• Last Updated: October 19, 2022

Record last verified: 2022-10

Locations

NL (1)