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

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

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• 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
• Study Completion Date: September 2004

Arms and Interventions

Outcome Measures

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

Eligibility Criteria

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

Criteria

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

Locations

Canada, Ontario

Mount Sinai Hospital

Toronto, Ontario, Canada, M5G 1X5

Sponsors and Collaborators

Mount Sinai Hospital, Canada

The Physicians' Services Incorporated Foundation

Investigators

• Principal Investigator: Sangeeta Mehta, MD; MOUNT SINAI HOSPITAL

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mehta S, Burry L, Martinez-Motta JC, Stewart TE, Hallett D, McDonald E, Clarke F, Macdonald R, Granton J, Matte A, Wong C, Suri A, Cook DJ; Canadian Critical Care Trials Group. A randomized trial of daily awakening in critically ill patients managed with a sedation protocol: a pilot trial. Crit Care Med. 2008 Jul;36(7):2092-9. doi: 10.1097/CCM.0b013e31817bff85.

• ClinicalTrials.gov Identifier: NCT00298493
• Other Study ID Numbers: MSH REB#00-0032-A
• First Posted: March 2, 2006
• Last Update Posted: March 2, 2006
• Last Verified: February 2006

Keywords provided by Mount Sinai Hospital, Canada:

ICU; Sedation strategies; Daily sedative interruption; Sedation protocols

Additional relevant MeSH terms:

Critical Illness; Disease Attributes; Pathologic Processes