Daily Sedative Interruption in Critically Ill Patients Being Managed With a Sedation Protocol

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. Identifier: NCT00298493
Recruitment Status : Completed
First Posted : March 2, 2006
Last Update Posted : March 2, 2006
The Physicians' Services Incorporated Foundation
Information provided by:
Mount Sinai Hospital, Canada

Brief Summary:
All critically ill, mechanically ventilated patients in the Intensive Care Unit receive medications to relieve pain and anxiety. However, accumulation of these medications can be associated with serious complications, most notably longer time on the breathing machine and in the ICU. Two strategies have been shown to dramatically improve patient outcomes: nurse-directed protocols for giving sedation, and daily interruption of sedation. However, these strategies have not been widely adopted, because of physicians' concerns, and because it is unclear which strategy is better. Given that patient outcome is improved with either of these strategies, the fundamental question that arises is whether patients managed with a combination of two strategies which both reduce drug accumulation (protocolized sedation and daily interruption) have an even better outcome than patients managed with only one of them (protocolized sedation). We propose a multicenter study in which 700 critically ill, mechanically ventilated patients will have their sedation managed with protocolized sedation alone, or both strategies. Both groups of patients will have the following recorded: ICU and hospital lengths of stay, mortality, total sedative drug use, ICU human resources used, side effects and recall of their ICU stay. The results of this large multi-center trial will help to inform best practice with regard to sedation management of critically ill patients in Canada and elsewhere. In addition, reducing ICU stay could be economically attractive, as the cost of an ICU day in Canada is approximately $3000.

Condition or disease Intervention/treatment Phase
Critical Illness Mechanical Ventilation Procedure: Sedation management strategy Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Daily Sedative Interruption in Critically Ill Patients Being Managed With a Sedation Protocol - A Pilot Study
Study Start Date : February 2001
Estimated Study Completion Date : September 2004

Primary Outcome Measures :
  1. Duration of Mechanical Ventilation
  2. ICU and Hospital Lengths of stay

Secondary Outcome Measures :
  1. Adverse events
  2. Patient Recall
  3. Caregiver workload

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  1. age>18 years
  2. Mechanically ventilated, with anticipated need for MV ≥ 48 hours
  3. ICU team has decided to initiate continuous sedative/analgesic infusion(s)
  4. informed consent.

Exclusion Criteria:

  1. Admission after resuscitation from cardiac arrest
  2. Traumatic brain injury
  3. Currently receiving neuromuscular blocking agents
  4. Allergy to any of the study medications
  5. History of alcohol, sedative or analgesic abuse
  6. History of psychiatric illness
  7. Acute or chronic neurologic dysfunction
  8. Administration of sedatives for >24 hr,
  9. Lack of commitment to aggressive treatment
  10. Current enrollment in a related trial
  11. Previous enrollment in this trial.

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 identifier (NCT number): NCT00298493

Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Mount Sinai Hospital, Canada
The Physicians' Services Incorporated Foundation
Principal Investigator: Sangeeta Mehta, MD Mount Sinai Hospital, New York

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00298493     History of Changes
Other Study ID Numbers: MSH REB#00-0032-A
First Posted: March 2, 2006    Key Record Dates
Last Update Posted: March 2, 2006
Last Verified: February 2006

Keywords provided by Mount Sinai Hospital, Canada:
Sedation strategies
Daily sedative interruption
Sedation protocols

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs