Study Stopped
Low recruitment ratio
Sedation With Sevoflurane Versus Propofol in Patients With Acute Respiratory Distress Syndrome Caused by COVID19 Infection
SEVO-COVID19
1 other identifier
interventional
19
1 country
5
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2020
Shorter than P25 for phase_4
5 active sites
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
Study Start
First participant enrolled
April 16, 2020
CompletedFirst Submitted
Initial submission to the registry
April 21, 2020
CompletedFirst Posted
Study publicly available on registry
April 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedJuly 27, 2021
July 1, 2021
12 months
April 21, 2020
July 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
PaO2/FiO2
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
Day 2
Secondary Outcomes (5)
TNFα
Day 2
IL-1b
Day 2
IL-6
Day 2
IL-8
Day 2
Mortality
Day 30
Study Arms (2)
SEVOFLURANE Group
EXPERIMENTALPROPOFOL Group
ACTIVE COMPARATORInterventions
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)
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Hospital Universitario Cruces
Barakaldo, Bizkaia, 48903, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Hospital General Universitario de Valencia
Valencia, 46014, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2020
First Posted
April 24, 2020
Study Start
April 16, 2020
Primary Completion
March 31, 2021
Study Completion
March 31, 2021
Last Updated
July 27, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share