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

May 7, 2008
September 23, 2011
January 2008
August 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00675363 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Daily Sedative Interruption in Critically Ill Patients Being Managed With a Sedation Protocol
A Randomized Trial of Daily Sedative Interruption in Critically Ill, Mechanically Ventilated Patients Being Managed With a Sedation Protocol

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Critical Illness
  • 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
  • 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
Mehta S, Burry L, Cook D, Fergusson D, Steinberg M, Granton J, Herridge M, Ferguson N, Devlin J, Tanios M, Dodek P, Fowler R, Burns K, Jacka M, Olafson K, Skrobik Y, Hébert P, Sabri E, Meade M; SLEAP Investigators; Canadian Critical Care Trials Group. Daily sedation interruption in mechanically ventilated critically ill patients cared for with a sedation protocol: a randomized controlled trial. JAMA. 2012 Nov 21;308(19):1985-92.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
410
November 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00675363
85487
Yes
Sangeeta Mehta, Mount Sinai Hospital, Canada
Mount Sinai Hospital, Canada
  • Canadian Institutes of Health Research (CIHR)
  • Ottawa Hospital Research Institute
Principal Investigator: Sangeeta Mehta, M.D. Mount Sinai Hospital, New York
Mount Sinai Hospital, Canada
September 2011

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