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Sedation and Psychopharmacology in Critical Care

This study has been terminated.
(End point reached at interim analysis)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00205517
First Posted: September 20, 2005
Last Update Posted: January 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
American Lung Association
Information provided by (Responsible Party):
Virginia Commonwealth University
  Purpose

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.


Condition Intervention
Sedation Mechanical Ventilation Depression Post-traumatic Stress Disorder Quality of Life Procedure: Daily interruption of sedation versus sedation algorithm

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics and Dynamics in Patients Randomized to Once Daily Awakening and Sedated According to Standardized Algorithm

Further study details as provided by Virginia Commonwealth University:

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

Enrollment: 75
Study Start Date: September 2002
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
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): NCT00205517


Sponsors and Collaborators
Virginia Commonwealth University
National Institutes of Health (NIH)
American Lung Association
Investigators
Principal Investigator: Marjolein de Wit, MD Virginia Commonwealth University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00205517     History of Changes
Other Study ID Numbers: K23GM068842 ( U.S. NIH Grant/Contract )
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: January 9, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders