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

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia (Other)

Overall Status

Terminated

CT.gov ID

NCT04359862

Collaborator

(none)

Enrollment

Locations

Arms

11.5

Actual Duration (Months)

3.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Multicenter, national, randomized, 1:1 ratio, controlled, parallel, open studyMulticenter, 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 :

Apr 16, 2020

Actual Primary Completion Date :

Mar 31, 2021

Actual Study Completion Date :

Mar 31, 2021

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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

TNFα [Day 2]
To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19
IL-1b [Day 2]
To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19
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
Mortality [Day 30]
To evaluate the 30-day mortality.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Cruces	Barakaldo	Bizkaia	Spain	48903
2	Hospital Universitario Ramón y Cajal	Madrid		Spain	28034
3	Hospital Universitario La Paz	Madrid		Spain	28046
4	Hospital Clínico Universitario de Valencia	Valencia		Spain	46010
5	Hospital General Universitario de Valencia	Valencia		Spain	46014