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Inhaled Anesthetic
Volatile Anesthetics for COVID-19 (SAVE-ICU Trial)
Phase 3
Recruiting
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Receiving IV sedation by infusion or bolus for ≤72 hours to facilitate mechanical ventilation
≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
SAVE-ICU Trial Summary
This trial is testing whether using gases to keep patients sedated while on a breathing machine is more effective than using drugs.
Who is the study for?
Adults over 18, on mechanical ventilation for severe lung failure possibly due to COVID-19, and expected to need it for at least another day. They should have been sedated via IV for no more than 72 hours and not allergic to the trial drugs. Excluded are those with high brain pressure, severe brain injury, certain lung or neuromuscular conditions, contraindications to specific sedatives, pregnant women or patients unlikely to survive a day.Check my eligibility
What is being tested?
The study compares inhaled anesthetics Sevoflurane and Isoflurane as alternatives for IV sedation in ICU patients with respiratory failure. It aims to see if these gases can improve survival rates, reduce time on ventilators and in hospitals by reducing lung inflammation and improving oxygen levels.See study design
What are the potential side effects?
Potential side effects of Sevoflurane and Isoflurane may include dizziness, coughing, nausea or vomiting after waking up from sedation. Rarely they might cause confusion or agitation upon waking.
SAVE-ICU Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on IV sedation for less than 72 hours to help with mechanical breathing.
Select...
I am 18 years old or older.
Select...
I am on strong pain medication through an IV to help with sedation or agitation while on a ventilator.
SAVE-ICU Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hospital Mortality
ICU-Free Days
Participant Quality of Life at 3 and 12 months after discharge
+1 moreSecondary outcome measures
Adjunctive ARDS therapies
Delirium and Coma Free Days
Disability
+2 moreSAVE-ICU Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Inhaled - volatile anestheticExperimental Treatment2 Interventions
The ICU patient will be randomized to either Isoflurane or Sevoflurane, whichever is available at the hospital. Dosage will be modified as per health care team guidance for the best treatment of the participant.
Group II: Non-randomizedActive Control1 Intervention
In this arm, ICU patients who cannot be randomized will receive inhaled or IV sedation as per available in their unit. This is done to try to obtain the maximum amount of information available from the patients present to our ICUs.
Group III: Standard CareActive Control1 Intervention
The ICU patient will be randomized to standard of care, which is any IV sedation supplied by the hospital. Dosage will be modified as per health care team guidance for the best treatment of the participant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sevoflurane
FDA approved
Find a Location
Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,550,550 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently using a breathing machine and will still need it tomorrow.I am on IV sedation for less than 72 hours to help with mechanical breathing.I have a severe brain injury likely to cause prolonged unconsciousness.I might have high pressure inside my skull.I was moved to a trial site and needed more help with breathing within the last 3 days.I am not using inhaled prostacyclin with a miniature vaporizer.I have or might have COVID-19, or I am COVID-19 negative but have a low oxygen level.I am 18 years old or older.I am on strong pain medication through an IV to help with sedation or agitation while on a ventilator.I am not allergic to the ingredients in the study drugs or to sevoflurane/isoflurane.I have had surgery to remove one lung or use only one lung for breathing.My breathing capacity is too low for certain inhaled treatments.I have a severe muscle disorder like ALS or Guillain-Barre Syndrome that required ICU care and a breathing machine.I cannot take certain sedatives due to severe reactions.You are very sick and not expected to live longer than 12 hours.
Research Study Groups:
This trial has the following groups:- Group 1: Non-randomized
- Group 2: Inhaled - volatile anesthetic
- Group 3: Standard Care
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are recruitment efforts for this experiment ongoing at present?
"The information available on clinicaltrials.gov suggests that this study is still recruiting patients. The trial was first posted on June 15th, 2020 and has had one update on April 9th, 2021."
Answered by AI
Can you give me a breakdown of where this research is taking place?
"This clinical trial has 12 enrolling patients at locations such as Universite de Sherbrooke in Sherbrooke, University of Alberta Hospital in Edmonton, and University Health Network - Toronto Western Hopsital in Toronto."
Answered by AI
Are there any other scientific papers that mention Isoflurane Inhalant Product?
"There are currently 43 separate studies underway that focus on Isoflurane Inhalant Product. Out of those, 9 are in Phase 3 clinical trials. The majority of research is based out of Seoul, but there are also 202 other locations running similar tests and investigations."
Answered by AI
Has the Isoflurane Inhalant Product received FDA approval?
"Isoflurane Inhalant Product is backed by Phase 3 trial data, meaning that there are both efficacy and safety data supporting its use. Therefore, it received a score of 3 from our team at Power."
Answered by AI
How many research subjects are involved in this clinical trial?
"That is correct, the clinicaltrials.gov website does show that this trial is looking for more participants. The study was originally posted on June 15th 2020 and received its last update on April 9th 2021. In total, 752 individuals are needed across 12 different enrolment locations."
Answered by AI
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