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Sedation With Sevoflurane Versus Propofol in Patients With Acute Respiratory Distress Syndrome Caused by COVID19 Infection (SEVO-COVID19)

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ClinicalTrials.gov Identifier: NCT04359862
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
Fundación para la Investigación del Hospital Clínico de Valencia

Brief Summary:

It is a multicenter, national, randomized 1:1 ratio, controlled, parallel, open study.

Patients with severe ARDS-CoVid19 will be included in the trial within the first 24 hours.

Patients will be randomized to one of the treatment groups:

  • SEV group: 25 patients with Sevoflurane sedation by inhalation, starting at 6 ml/h and changing every 15 minutes until an adequate level of sedation is achieved (BIS 40-50)
  • PRO group: 25 patients standard sedation with intravenous propofol, starting with 2 mg/kg/h and changing every 15 minutes until an adequate level of sedation is achieved ( BIS 40-50)

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome COVID19 Infection Drug: Sevoflurane Drug: Propofol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, national, randomized, 1:1 ratio, controlled, parallel, open study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sedation With Sevoflurane Versus Propofol in Patients With Acute Respiratory Distress Syndrome Caused by COVID19 Infection
Actual Study Start Date : April 16, 2020
Estimated Primary Completion Date : August 16, 2020
Estimated Study Completion Date : September 16, 2020


Arm Intervention/treatment
Experimental: SEVOFLURANE Group Drug: Sevoflurane
25 patients sedated with Sevoflurane via inhalation, starting with 6 ml/h and changing every 15 minutes until an adequate level of sedation is achieved ( BIS 40-50)

Active Comparator: PROPOFOL Group Drug: Propofol
25 patients standard sedation with intravenous propofol, starting with 2 mg/kg/h and changing every 15 minutes until an adequate level of sedation is achieved ( BIS 40-50)




Primary Outcome Measures :
  1. PaO2/FiO2 [ Time Frame: Day 2 ]
    To evaluate the effect of 48-hour treatment with inhaled sevoflurane on arterial oxygenation, assessed by PaO2/FiO2 on day two, in patients with ARDS-CoVid19


Secondary Outcome Measures :
  1. TNFα [ Time Frame: Day 2 ]
    To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19

  2. IL-1b [ Time Frame: Day 2 ]
    To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19

  3. IL-6 [ Time Frame: Day 2 ]
    To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19

  4. IL-8 [ Time Frame: Day 2 ]
    To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19

  5. Mortality [ Time Frame: Day 30 ]
    To evaluate the 30-day mortality.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or more.
  • Diagnosis of Acute Respiratory Distress Syndrome caused by COVID19 infection.
  • Signature of Patient's Consent or Verbal Consent of Legal Representative

Exclusion Criteria:

  • Intracranial hypertension
  • Hypersensitivity to the active ingredient (propofol or sevoflurane) or to any of the excipients
  • Current volume < 250ml
  • History of malignant hyperthermia
  • Liver failure
  • Neutropenia (<0.5x109)
  • Pregnant or lactating women
  • Have received chemotherapy in the last month since their inclusion in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04359862


Contacts
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Contact: Rafael Badenes, PhD 0034961973500 rafaelbadenes@gmail.com

Locations
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Spain
Hospital Universitario Ramón y Cajal Recruiting
Madrid, Spain, 28034
Contact: David Pestaña         
Hospital Universitario La Paz Not yet recruiting
Madrid, Spain, 28046
Contact: Emilio Maseda, PhD         
Hospital Clínico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Contact: Rafael Badenes, PhD       rafaelbadenes@gmail.com   
Hospital Clínico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Contact: José Manuel Segura         
Hospital General Universitario de Valencia Recruiting
Valencia, Spain, 46014
Contact: Jaume Puig, PhD         
Sponsors and Collaborators
Fundación para la Investigación del Hospital Clínico de Valencia
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Responsible Party: Fundación para la Investigación del Hospital Clínico de Valencia
ClinicalTrials.gov Identifier: NCT04359862    
Other Study ID Numbers: SEVO-COVID19
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation