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

Acute Respiratory Distress Syndrome Clinical Trial

— SEVO-COVID19  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04359862
• Other study ID #: SEVO-COVID19
• Status: Terminated
• Phase: Phase 4
• Start date: April 16, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: July 2021
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Communicable Diseases
• COVID19 Infection
• Infection
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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)
• 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)

Locations

Country	Name	City	State
Spain	Hospital Universitario Cruces	Barakaldo	Bizkaia
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital General Universitario de Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para la Investigación del Hospital Clínico de Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	TNFa	To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19	Day 2
Secondary	IL-1b	To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19	Day 2
Secondary	IL-6	To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19	Day 2
Secondary	IL-8	To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19	Day 2
Secondary	Mortality	To evaluate the 30-day mortality.	Day 30