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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Mount Sinai Hospital, Canada.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Ottawa Hospital Research Institute
Information provided by (Responsible Party):
Sangeeta Mehta, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT00675363
First received: May 7, 2008
Last updated: September 23, 2011
Last verified: September 2011
  Purpose

The purpose of this study is to determine whether the use of both a nurse-driven sedation protocol and daily sedative interruption, compared with a sedation protocol alone, result in better outcomes for mechanically ventilated adults.


Condition Intervention
Critical Illness
Procedure: Protocolized Sedation
Procedure: Protocolized sedation, with daily interruption

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized Trial of Daily Sedative Interruption in Critically Ill, Mechanically Ventilated Patients Being Managed With a Sedation Protocol

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

Primary Outcome Measures:
  • time to successful extubation [ Time Frame: This will be the length of time that the patient remains on continuous infusions of sedation and/or analgesia in the ICU. At 60 days, all study interventions will terminate, but patients will be followed for outcomes. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ICU and hospital lengths of stay, ICU and hospital mortality, Adverse events (e.g., self -removal of endotracheal tube) [ Time Frame: This will be the length of time that the patient remains on continuous infusions of sedation and/or analgesia in the ICU. At 60 days, all study interventions will terminate, but patients will be followed for outcomes. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 410
Study Start Date: January 2008
Estimated Study Completion Date: November 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PS
Nurse-directed protocols for administering sedation and/or analgesia by continuous infusion.
Procedure: Protocolized Sedation
Nurse-directed protocol for administering sedation and/or analgesia.
Active Comparator: PS + DI
Nurse-directed protocols for administering sedation and/or analgesia, with daily interruption of sedation/analgesia
Procedure: Protocolized sedation, with daily interruption
Nurse-directed protocols for administering sedation and/or analgesia, with daily interruption of sedation/analgesia

Detailed Description:

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 are conducting a multicenter randomized trial in which 400 critically ill, mechanically ventilated patients will have their sedation managed with protocolized sedation alone, or both strategies. Primary outcomes are duration of mechanical ventilation and ICU and hospital lengths of stay. Secondary outcomes are the incidence of delirium, the use of neurologic tests, nurse and respiratory therapist effort associated with the sedation management, the incidence of patient self-removal of lines and tubes, and patient recall of the 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or over
  • Mechanically ventilated, with anticipated need for MV ≥48 hrs
  • ICU team has decided to initiate continuous sedative/analgesic infusion(s)
  • informed consent from patient and/or SDM

Exclusion Criteria

  • Admission after resuscitation from cardiac arrest
  • Traumatic brain injury
  • Currently receiving neuromuscular blocking agents
  • Allergy to midazolam and lorazepam
  • Lack of commitment to aggressive treatment
  • Previous enrolment in SLEAP, or current enrolment in related 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 ClinicalTrials.gov identifier: NCT00675363

Locations
United States, California
Long Beach Memorial Medical Center
Long Beach, California, United States
United States, Massachusetts
Tuft's Medical Centre
Boston, Massachusetts, United States
Canada, Alberta
Walter C. Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada, T6G 2B7
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
Canada, British Columbia
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 3W7
Providence Health Care-St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Surrey Memorial Hospital
Vancouver, British Columbia, Canada, V3W 1Z2
Canada, Manitoba
Winnipeg Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
St. Joesph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sunnybrook HSC
Toronto, Ontario, Canada, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Maisonneuve Rosemount
Montreal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Canadian Institutes of Health Research (CIHR)
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Sangeeta Mehta, M.D. Mount Sinai Hospital, New York
  More Information

No publications provided by Mount Sinai Hospital, Canada

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sangeeta Mehta, M.D., Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT00675363     History of Changes
Other Study ID Numbers: 85487
Study First Received: May 7, 2008
Last Updated: September 23, 2011
Health Authority: Canada: Health Canada
Canada: Canadian Institutes of Health Research

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

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

ClinicalTrials.gov processed this record on October 22, 2014