800 Participants Needed

Volatile Anesthetics for COVID-19

(SAVE-ICU Trial)

Recruiting at 12 trial locations
KS
AJ
IH
Overseen ByIman Hussain
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Sunnybrook Health Sciences Centre
Must be taking: Intravenous sedatives
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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

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 was moved to a trial site and needed more help with breathing within the last 3 days.
See 2 more

Exclusion Criteria

I have a severe brain injury likely to cause prolonged unconsciousness.
Known pregnancy
I might have high pressure inside my skull.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive either intravenous or inhaled volatile-based sedation, randomized within 72 hours of sedation start

30 days
Daily visits in ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 30, 60, 90, and 365 days post-enrollment

12 months
Telephone or database follow-up at specified intervals

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
Trial Overview 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.
Participant Groups
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.

Isoflurane Inhalant Product is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Forane for:
  • General anesthesia
  • Maintenance of anesthesia
🇪🇺
Approved in European Union as Isoflurane for:
  • Induction and maintenance of general anesthesia
🇨🇦
Approved in Canada as Isoflurane for:
  • General anesthesia
🇯🇵
Approved in Japan as Isoflurane for:
  • General anesthesia

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials
693
Recruited
1,569,000+

Findings from Research

The proposed maximum admissible concentrations (MAC) for sevoflurane and isoflurane are 55 mg/m3 (7 ppm) and 32 mg/m3 (4 ppm), respectively, which aim to protect surgical staff from potential health risks associated with these anesthetics.
Establishing these MAC values is crucial as it provides a guideline for employers to assess and manage exposure to these inhalant anesthetics in the workplace, ensuring the safety of healthcare workers.
[Assessment of health risk of sevoflurane and isoflurane exposure among surgical staff: a problem for employers].Kupczewska-Dobecka, M., Soćko, R.[2018]
Sevoflurane, an inhalation anesthetic, is available in the U.S. as both a brand (Ultane) and a generic version, with the FDA rating them as therapeutically equivalent despite differences in their manufacturing processes.
Ultane is produced through a single-step process and contains more water (>300 ppm) compared to the generic version, which is made in a three-step process and contains less water (≤130 ppm), potentially affecting stability and efficacy.
Sevoflurane: are there differences in products?Baker, MT.[2018]
Four out of 13 sevoflurane vaporizers were contaminated with water and Staphylococcus epidermidis, indicating a potential safety risk in their use.
The contamination was linked to water accumulation in the vaporizers, which can lead to the production of harmful metabolites, including urea and other organic compounds, highlighting the importance of proper maintenance and monitoring of anesthesia equipment.
Sevoflurane Contamination: Water Accumulation in Sevoflurane Vaporizers Can Allow Bacterial Growth in the Vaporizer.Wallace, AW.[2022]

References

[Assessment of health risk of sevoflurane and isoflurane exposure among surgical staff: a problem for employers]. [2018]
Sevoflurane: are there differences in products? [2018]
Sevoflurane Contamination: Water Accumulation in Sevoflurane Vaporizers Can Allow Bacterial Growth in the Vaporizer. [2022]
Randomized Comparison of Isoflurane versus Sevoflurane and Desflurane for Maintenance of Ambulatory Anesthesia. [2022]
Maintenance and recovery characteristics of sevoflurane anaesthesia in adult patients. A multicenter, randomized comparison with isoflurane. [2018]
Immediate Infusion Reaction to Intravenous Ustekinumab in Three Crohn's Disease Patients: A Case Report and Review of the Literature. [2021]
The safety of ustekinumab in psoriasis. [2015]
8.Russia (Federation)pubmed.ncbi.nlm.nih.gov
Sorption of Interleukins 12 and 23 Using the Developed Magnetocontrollable Ustekinumab-Based Sorbent. [2022]
Population Pharmacokinetics and Exposure-Response Modeling Analyses of Ustekinumab in Adults With Moderately to Severely Active Ulcerative Colitis. [2021]
Intravenous ustekinumab maintenance treatment in patients with loss of response to subcutaneous dosing. [2023]
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