Sedation and Psychopharmacology in Critical Care
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|ClinicalTrials.gov Identifier: NCT00205517|
Recruitment Status : Terminated (End point reached at interim analysis)
First Posted : September 20, 2005
Last Update Posted : January 9, 2013
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 or disease||Intervention/treatment||Phase|
|Sedation Mechanical Ventilation Depression Post-traumatic Stress Disorder Quality of Life||Procedure: Daily interruption of sedation versus sedation algorithm||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetics and Dynamics in Patients Randomized to Once Daily Awakening and Sedated According to Standardized Algorithm|
|Study Start Date :||September 2002|
|Actual Primary Completion Date :||July 2006|
|Actual Study Completion Date :||July 2006|
- Length of mechanical ventilation and ICU stay. Mortality
- Physical and emotional well being. Length of time return to work. Morbidity assessed by questionnaire
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
|Principal Investigator:||Marjolein de Wit, MD||Virginia Commonwealth University|