Sedation With Sevoflurane Versus Propofol in Patients With Acute Respiratory Distress Syndrome Caused by COVID19 Infection

Phase 4

Terminated

• Conditions: Acute Respiratory Distress Syndrome; COVID19 Infection
• Interventions: Drug: Sevoflurane; Drug: Propofol

• Registration Number: NCT04359862
• Lead Sponsor: 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-16
• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-04-21
• Study First Posted: 2020-04-24
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SEVOFLURANE Group	Sevoflurane	-
PROPOFOL Group	Propofol	-

Primary Outcome Measures

Name	Time	Method
PaO2/FiO2	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

Name	Time	Method
IL-1b	Day 2	To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19
Mortality	Day 30	To evaluate the 30-day mortality.
IL-6	Day 2	To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19
IL-8	Day 2	To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19
TNFα	Day 2	To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19

Trial Locations

Locations (5)

Hospital Universitario Cruces; 🇪🇸 Barakaldo, Bizkaia, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital General Universitario de Valencia; 🇪🇸 Valencia, Spain