Sedation and Psychopharmacology in Critical Care

This study has been terminated.
(End point reached at interim analysis)
Sponsor:
Collaborators:
American Lung Association
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00205517
First received: September 12, 2005
Last updated: January 7, 2013
Last verified: January 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00205517

Sponsors and Collaborators
Virginia Commonwealth University
American Lung Association
Investigators
Principal Investigator: Marjolein de Wit, MD Virginia Commonwealth University
  More Information

No publications provided by Virginia Commonwealth University

Additional 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, K23GM068842
Study First Received: September 12, 2005
Last Updated: January 7, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Depression
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014