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SedAting With Volatile Anesthetics Critically Ill COVID-19 Patients in ICU: Effects On Ventilatory Parameters And Survival

Study acronym: SAVE-ICU
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 9, 2026 (before its estimated March 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv12
  2. Primary endpoints: 4 to 1
    • Trial status: Recruiting to Active, Not Recruiting
    • Secondary endpoints: 5 to 8
    • Site details revised at 13 of 13 sites
    v11
  3. Primary endpoints revised (4)v10
  4. Primary completion date: Jun 15, 2024 to Mar 31, 2026v9 Show 4 more changesShow less
    • Enrollment target: 758 to 800
    • Study sites: 12 to 13
    • Study completion date: Jun 15, 2025 to Jun 15, 2027
    • Eligibility criteria expanded, about 26 words
  5. Enrollment target: 752 to 758v8
Show 6 earlier versionsHide 6 earlier versions
  1. Primary completion date: Jun 15, 2023 to Jun 15, 2024v7 Show 5 more changesShow less
    • Study completion date: Jun 15, 2023 to Jun 15, 2025
    • Secondary endpoints: 6 to 5
    • Study description shortened, about 62 words
    • Site details revised at 6 of 12 sites
    • Eligibility criteria expanded, about 1 word
  2. Study sites: 10 to 12
    • Eligibility criteria expanded, about 34 words
    v6
  3. Study sites: 8 to 10
    • Eligibility criteria expanded, about 140 words
    • Secondary endpoints revised (6)
    v5
  4. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary and study completion dates: Jun 15, 2022 to Jun 15, 2023
    • Eligibility criteria expanded, about 7 words
    • Site details revised at 8 of 8 sites
    • Study description expanded, about 5 words
  5. Study sites: 2 to 8v3
  6. Secondary endpoints: details revised at 3 of 6 entriesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04415060
Lead Sponsor Sunnybrook Health Sciences Centre
Conditions
(from sponsor)		 Covid19, Hypoxic Respiratory Failure
Related terms COVID-19
Enrollment 800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov