Volatile Anesthetics for COVID-19
(SAVE-ICU Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that patients already receiving certain intravenous sedatives are eligible, so you might be able to continue some medications.
Is the use of volatile anesthetics like sevoflurane and isoflurane generally safe for humans?
Sevoflurane and isoflurane are commonly used anesthetics in surgeries for both adults and children, and they are generally considered safe when used properly. However, there are concerns about exposure levels for surgical staff, as high concentrations can cause adverse effects on the nervous system, heart, and lungs. Proper safety measures and monitoring are important to minimize these risks.12345
How is the drug Isoflurane and Sevoflurane unique for treating COVID-19?
Isoflurane and Sevoflurane are unique for treating COVID-19 because they are inhaled anesthetics, typically used during surgeries to keep patients asleep, and their use for COVID-19 is novel as they are not standard treatments for this condition. This approach is different from other COVID-19 treatments, which are usually administered orally or intravenously.678910
What is the purpose of this trial?
Patients suffering lung failure, possibly from COVID-19 or hypoxic lung failure, will need life-saving support from a breathing machine. Any patient needing this support requires drugs to keep them sleepy, or "sedated" to be comfortable on this machine. Sedation is made possible by using drugs given through a vein. Unfortunately, these drugs are in short supply worldwide due to the high number of COVID-19 patients needing these machines.Another way to provide sleep is by using gases that are breathed in. These are used every day in operating rooms to perform surgery. These gases, also called "inhaled agents" can also be used in intensive care units and may have several important benefits for patients and the hospital. Research shows they may reduce swelling in the lung and increase oxygen levels, which allows patients to recover faster and reduce the time spent on a breathing machine. In turn, this allows the breathing machine to be used again for the next sick patient. These drugs may also increase the number of patients who live through their illness. Inhaled agents are widely available and their use could dramatically lesson the pressure on limited drug supplies.This research is a study being carried out in a number of hospitals that will compare how well patients recover from these illnesses depending on which type of sedation drug they receive. The plan is to evaluate the number who survive, their time spent on a breathing machine and time in the hospital. This study may show immediate benefits and may provide a cost effective and practical solution to the current challenges caring for patients and the hospital space, equipment and drugs to the greatest benefit. Furthermore, the study will be investigating inflammatory profile and neuro-cognitive profiles in ventilated patients. Finally, this trial will be a team of experts in sedation drugs who care for patients with proven or suspected COVID-19 who need lifesaving treatments.
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either intravenous or inhaled volatile-based sedation, randomized within 72 hours of sedation start
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 30, 60, 90, and 365 days post-enrollment
Neuro-cognitive and Biomarker Assessment (optional)
Participants have the option to participate in additional neuro-cognitive and biomarker assessments
Treatment Details
Interventions
- Isoflurane Inhalant Product
- Sevoflurane inhalant product
Isoflurane Inhalant Product is already approved in United States, European Union, Canada, Japan for the following indications:
- General anesthesia
- Maintenance of anesthesia
- Induction and maintenance of general anesthesia
- General anesthesia
- General anesthesia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sunnybrook Health Sciences Centre
Lead Sponsor