ARDSPhase 4NCT04014218
Effect of Inhalation Sedation Compared With Propofol on the Sepsis-related Acute Respiratory Distress Syndrome Course
A Phase 4 study testing Inhalation Sedation and Intravenous Sedation in people with ARDS, run by Moscow Regional Research and Clinical Institute (MONIKI) at 1 site in Russia.
Trial summary
Investigation of effect of inhalation sedation by administration of Sevoflurane compared with Propofol on the moderate acute respiratory distress syndrome course in mechanically ventilated patients with sepsis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ARDS
- What is being tested?
- Inhalation Sedation and Intravenous Sedation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteRussia
- Study dates
- 8 Jan 2019to Jan 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sepsis
- ARDS
- P/F Ratio 100-250
- start of mechanical ventilation
Who cannot join
- pregnancy
- concomitant oncological disease
- prior psychological impairment
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
Moscow, 129110
Valery V Likhvantsev, Professor, +7 (903) 623-59-82, lik0704@gmail.com
About this study
Official title: Effect of Inhalation Sedation With Sevoflurane Compared With Propofol on the Sepsis-related Acute Respiratory Distress Syndrome (ARDS) Course.
Investigation of effect of inhalation sedation by administration of Sevoflurane compared with Propofol on the moderate acute respiratory distress syndrome course in mechanically ventilated patients with sepsis.
- Conditions
- ARDS
- Being tested
- Inhalation Sedation, Intravenous Sedation
- Keywords
- sedation, ARDS, sepsis, outcome
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhalation SedationDrug
Inhalation Sedation by Administration of Sevoflurane
Intravenous SedationDrug
Intravenous Sedation by Administration of Propofol
| Study group | Role | What they receive |
|---|---|---|
| Inhalation sedation | Experimental | Not described Receives: Drug: Inhalation Sedation |
| Propofol | Active comparator | Not described Receives: Drug: Intravenous Sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
28 days and in-hospital mortality
Measured: 28 days after ICU admission
ICU Length of stay (LOS)
Length of stay in ICU
Measured: 45 days after ICU admission
Length of mechanical ventilation (LMV)
Length of mechanical ventilation
Measured: 45 days after ICU admission
Secondary outcomes (4)
P/F Ratio
minimal pO2/FiO2
Measured: 45 days after ICU admission
Delirium
onset and duration of delirium
Measured: 5 days after ICU admission
MACCE
Major Adverse Cardiac and Cerebrovascular Event
Measured: 28 days after ICU admission
event of RRT
event of Renal Replacement Therapy
Measured: 28 days after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start8 Jan 2019
- Primary completionSep 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moscow Regional Research and Clinical Institute (MONIKI)
- Sponsor type
- Other government
- Collaborators
- I.M. Sechenov First Moscow State Medical University
- Responsible party
- Principal investigator, Valery V. Likhvantsev, Professor, Moscow Regional Research and Clinical Institute (MONIKI)
- Investigators
- Valery V Likhvantsev,, Principal investigator, Moscow Regional Clinical and Research Institute, Department of Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014218
- Sponsor's protocol ID
- SS2019
- Status last verified
- Jul 2019
- First submitted
- 2 Jul 2019
- Last updated
- 10 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inhalation Sedation With Sevoflurane Compared With Propofol on the Sepsis-related Acute Respiratory Distress Syndrome (ARDS) Course.
- ClinicalTrials.gov ID
- NCT04014218
- Acronym / sponsor ID
- SS2019
- Conditions
- ARDS
- Keywords
- sedation, ARDS, sepsis, outcome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Moscow Regional Research and Clinical Institute (MONIKI)Other government
- Collaborators
- I.M. Sechenov First Moscow State Medical University
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigation of effect of inhalation sedation by administration of Sevoflurane compared with Propofol on the moderate acute respiratory distress syndrome course in mechanically ventilated patients with sepsis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhalation sedation | Experimental | Drug: Inhalation Sedation |
| Propofol | Active comparator | Drug: Intravenous Sedation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- sepsis
- ARDS
- P/F Ratio 100-250
- start of mechanical ventilation
Key exclusion criteria (3 listed)
- pregnancy
- concomitant oncological disease
- prior psychological impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhalation SedationInhalation Sedation by Administration of Sevoflurane | Drug | Inhalation sedation |
| Intravenous SedationIntravenous Sedation by Administration of Propofol | Drug | Propofol |
Primary outcome
mortality
Time frame: 28 days after ICU admission
28 days and in-hospital mortality
ICU Length of stay (LOS)
Time frame: 45 days after ICU admission
Length of stay in ICU
Length of mechanical ventilation (LMV)
Time frame: 45 days after ICU admission
Length of mechanical ventilation
4 secondary outcomes
P/F Ratio
Time frame: 45 days after ICU admission
Delirium
Time frame: 5 days after ICU admission
MACCE
Time frame: 28 days after ICU admission
event of RRT
Time frame: 28 days after ICU admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valery V Likhvantsev, principal investigator
Moscow Regional Clinical and Research Institute, Department of Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inhalation Sedation and Intravenous Sedation in people with ARDS, run by Moscow Regional Research and Clinical Institute (MONIKI) at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valery V Likhvantsev, (+7 (903) 623-59-82, lik0704@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 28 days after ICU admission). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.