Sedation and Psychopharmacology in Critical Care

Depression Clinical Trial

Official title:

Pharmacokinetics and Dynamics in Patients Randomized to Once Daily Awakening and Sedated According to Standardized Algorithm

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00205517
• Other study ID #: K23GM068842
• Secondary ID: K23GM068842
• Status: Terminated
• Phase: N/A
• First received: September 12, 2005
• Last updated: January 7, 2013
• Start date: September 2002
• Est. completion date: July 2006

Study information

• Verified date: January 2013
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Mechanical Ventilation
• Post-traumatic Stress Disorder
• Quality of Life
• Sedation
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Procedure:
• Daily interruption of sedation versus sedation algorithm

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Virginia Commonwealth University	American Lung Association, National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of mechanical ventilation and ICU stay. Mortality
Secondary	Physical and emotional well being. Length of time return to work. Morbidity assessed by questionnaire