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Sedation and Psychopharmacology in Critical Care

NCT00205517 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2013-01-09

No results posted yet for this study

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.

Conditions

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

Interventions

PROCEDURE

Daily interruption of sedation versus sedation algorithm

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • American Lung Association

    collaborator OTHER

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Marjolein de Wit, MD · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-09-30
Primary Completion
2006-07-31
Completion
2006-07-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00205517 on ClinicalTrials.gov