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Effect of Inhalation Sedation Compared With Propofol on the Sepsis-related Acute Respiratory Distress Syndrome Course

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ClinicalTrials.gov Identifier: NCT04014218
Recruitment Status : Recruiting
First Posted : July 10, 2019
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
I.M. Sechenov First Moscow State Medical University
Information provided by (Responsible Party):
Valery V. Likhvantsev, Professor, Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy

Brief 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.

Condition or disease Intervention/treatment Phase
ARDS Drug: Inhalation Sedation Drug: Intravenous Sedation Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: opaque envelopes
Primary Purpose: Treatment
Official Title: Effect of Inhalation Sedation With Sevoflurane Compared With Propofol on the Sepsis-related Acute Respiratory Distress Syndrome (ARDS) Course.
Actual Study Start Date : January 8, 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : January 2020


Arm Intervention/treatment
Experimental: Inhalation sedation Drug: Inhalation Sedation
Inhalation Sedation by Administration of Sevoflurane

Active Comparator: Propofol Drug: Intravenous Sedation
Intravenous Sedation by Administration of Propofol




Primary Outcome Measures :
  1. mortality [ Time Frame: 28 days after ICU admission ]
    28 days and in-hospital mortality

  2. ICU Length of stay (LOS) [ Time Frame: 45 days after ICU admission ]
    Length of stay in ICU

  3. Length of mechanical ventilation (LMV) [ Time Frame: 45 days after ICU admission ]
    Length of mechanical ventilation


Secondary Outcome Measures :
  1. P/F Ratio [ Time Frame: 45 days after ICU admission ]
    minimal pO2/FiO2

  2. Delirium [ Time Frame: 5 days after ICU admission ]
    onset and duration of delirium

  3. MACCE [ Time Frame: 28 days after ICU admission ]
    Major Adverse Cardiac and Cerebrovascular Event

  4. event of RRT [ Time Frame: 28 days after ICU admission ]
    event of Renal Replacement Therapy



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • sepsis
  • ARDS
  • P/F Ratio 100-250
  • start of mechanical ventilation

Exclusion Criteria:

  • pregnancy
  • concomitant oncological disease
  • prior psychological impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04014218


Contacts
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Contact: Valery V Likhvantsev, +7 (903) 623-59-82 lik0704@gmail.com

Locations
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Russian Federation
Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy Recruiting
Moscow, Russian Federation, 129110
Contact: Valery V Likhvantsev, Professor    +7 (903) 623-59-82    lik0704@gmail.com   
Sponsors and Collaborators
Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
I.M. Sechenov First Moscow State Medical University
Investigators
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Principal Investigator: Valery V Likhvantsev, Moscow Regional Clinical and Research Institute, Department of Intensive Care
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Responsible Party: Valery V. Likhvantsev, Professor, Professor, Head of Intensive Care Department Moscow Regional Clinical and Research Institute, Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
ClinicalTrials.gov Identifier: NCT04014218    
Other Study ID Numbers: SS2019
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Valery V. Likhvantsev, Professor, Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy:
sedation
ARDS
sepsis
outcome
Additional relevant MeSH terms:
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Sepsis
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury