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Sedation and Psychopharmacology in Critical Care

Primary Purpose

Sedation, Mechanical Ventilation, Depression

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Daily interruption of sedation versus sedation algorithm
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sedation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients aged 18 and older undergoing mechanical ventilation via naso- or orotracheal tube - Exclusion Criteria: Age less than 18, tracheotomy, severe dementia or mental retardation, severe neuromuscular disease or neuromuscular blockade use, institution of mechanical ventilation at another hospital -

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Length of mechanical ventilation and ICU stay. Mortality

    Secondary Outcome Measures

    Physical and emotional well being. Length of time return to work. Morbidity assessed by questionnaire

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    January 7, 2013
    Sponsor
    Virginia Commonwealth University
    Collaborators
    National Institutes of Health (NIH), American Lung Association
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00205517
    Brief Title
    Sedation and Psychopharmacology in Critical Care
    Official Title
    Pharmacokinetics and Dynamics in Patients Randomized to Once Daily Awakening and Sedated According to Standardized Algorithm
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2013
    Overall Recruitment Status
    Terminated
    Why Stopped
    End point reached at interim analysis
    Study Start Date
    September 2002 (undefined)
    Primary Completion Date
    July 2006 (Actual)
    Study Completion Date
    July 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Virginia Commonwealth University
    Collaborators
    National Institutes of Health (NIH), American Lung Association

    4. Oversight

    5. Study Description

    Brief Summary
    Certain methods of sedation increase the duration of respiratory failure. Two strategies, a nursing- implemented sedation algorithm and daily interruption of sedatives, decrease length of mechanical ventilation compared to "conventional care" but have not been compared to each other. The reason certain methods of sedation lead to prolonged respiratory failure is unknown but may be related to altered pharmacokinetics and dynamics that are unique to critically ill patients. Critically ill patients receive substantial doses of sedatives over prolonged periods. The impact of these management strategies on short- and long-term psychiatric complications are unknown. The study seeks to test the central hypothesis that sedation practices impact strongly on outcome of respiratory failure and psychiatric complications. The three specific aims are (1) to compare two sedation strategies (protocol directed sedation and daily interruption of sedatives), (2) to examine the prevalence of psychiatric complications, and (3) to compute the pharmacokinetics of commonly used sedatives and narcotics. These aims will be achieved by enrolling critically ill patients in a prospective randomized trial comparing the above mentioned sedation strategies, and assessing sedation level as well as delirium throughout the duration of respiratory failure. Sedative plasma levels will be measured, and pharmacokinetics computed. Psychiatric morbidity will be assessed by administration of validated questionnaires.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sedation, Mechanical Ventilation, Depression, Post-traumatic Stress Disorder, Quality of Life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    75 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Daily interruption of sedation versus sedation algorithm
    Primary Outcome Measure Information:
    Title
    Length of mechanical ventilation and ICU stay. Mortality
    Secondary Outcome Measure Information:
    Title
    Physical and emotional well being. Length of time return to work. Morbidity assessed by questionnaire

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients aged 18 and older undergoing mechanical ventilation via naso- or orotracheal tube - Exclusion Criteria: Age less than 18, tracheotomy, severe dementia or mental retardation, severe neuromuscular disease or neuromuscular blockade use, institution of mechanical ventilation at another hospital -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marjolein de Wit, MD
    Organizational Affiliation
    Virginia Commonwealth University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18492267
    Citation
    de Wit M, Gennings C, Jenvey WI, Epstein SK. Randomized trial comparing daily interruption of sedation and nursing-implemented sedation algorithm in medical intensive care unit patients. Crit Care. 2008;12(3):R70. doi: 10.1186/cc6908. Epub 2008 May 20.
    Results Reference
    derived

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    Sedation and Psychopharmacology in Critical Care

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