Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
The Physicians' Services Incorporated Foundation
Information provided by:
Mount Sinai Hospital, Canada Identifier:
First received: February 28, 2006
Last updated: NA
Last verified: February 2006
History: No changes posted

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 Intervention Phase
Critical Illness
Mechanical Ventilation
Procedure: Sedation management strategy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:
  • Duration of Mechanical Ventilation
  • ICU and Hospital Lengths of stay

Secondary Outcome Measures:
  • Adverse events
  • Patient Recall
  • Caregiver workload

Estimated Enrollment: 65
Study Start Date: February 2001
Estimated Study Completion Date: September 2004

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

No publications provided by Mount Sinai Hospital, Canada

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00298493     History of Changes
Other Study ID Numbers: MSH REB#00-0032-A
Study First Received: February 28, 2006
Last Updated: February 28, 2006
Health Authority: Canada: Health Canada

Keywords provided by Mount Sinai Hospital, Canada:
Sedation strategies
Daily sedative interruption
Sedation protocols processed this record on March 01, 2015