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

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ClinicalTrials.gov Identifier: NCT00675363
Recruitment Status : Completed
First Posted : May 9, 2008
Last Update Posted : March 23, 2018
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Ottawa Hospital Research Institute
Information provided by (Responsible Party):
Sangeeta Mehta, Mount Sinai Hospital, Canada

Tracking Information
First Submitted Date  ICMJE May 7, 2008
First Posted Date  ICMJE May 9, 2008
Last Update Posted Date March 23, 2018
Study Start Date  ICMJE January 2008
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2008)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2008)
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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Daily Sedative Interruption in Critically Ill Patients Being Managed With a Sedation Protocol
Official Title  ICMJE A Randomized Trial of Daily Sedative Interruption in Critically Ill, Mechanically Ventilated Patients Being Managed With a Sedation Protocol
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Critical Illness
Intervention  ICMJE
  • Procedure: Protocolized Sedation
    Nurse-directed protocol for administering sedation and/or analgesia.
  • Procedure: Protocolized sedation, with daily interruption
    Nurse-directed protocols for administering sedation and/or analgesia, with daily interruption of sedation/analgesia
Study Arms  ICMJE
  • Active Comparator: PS
    Nurse-directed protocols for administering sedation and/or analgesia by continuous infusion.
    Intervention: Procedure: Protocolized Sedation
  • Active Comparator: PS + DI
    Nurse-directed protocols for administering sedation and/or analgesia, with daily interruption of sedation/analgesia
    Intervention: Procedure: Protocolized sedation, with daily interruption
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 8, 2008)
410
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 17, 2012
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00675363
Other Study ID Numbers  ICMJE 85487
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sangeeta Mehta, Mount Sinai Hospital, Canada
Study Sponsor  ICMJE Mount Sinai Hospital, Canada
Collaborators  ICMJE
  • Canadian Institutes of Health Research (CIHR)
  • Ottawa Hospital Research Institute
Investigators  ICMJE
Principal Investigator: Sangeeta Mehta, M.D. MOUNT SINAI HOSPITAL
PRS Account Mount Sinai Hospital, Canada
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP