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

Critical Illness Clinical Trial

— SLEAP  

Official title:

A Randomized Trial of Daily Sedative Interruption in Critically Ill, Mechanically Ventilated Patients Being Managed With a Sedation Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00675363
• Other study ID #: 85487
• Status: Completed
• Phase: N/A
• First received: May 7, 2008
• Last updated: March 22, 2018
• Start date: January 2008
• Est. completion date: October 17, 2012

Study information

• Verified date: March 2018
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: October 17, 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

Procedure:
• Protocolized Sedation
Nurse-directed protocol for administering sedation and/or analgesia.
• Protocolized sedation, with daily interruption
Nurse-directed protocols for administering sedation and/or analgesia, with daily interruption of sedation/analgesia

Locations

Country	Name	City	State
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	Walter C. Mackenzie Health Sciences Centre	Edmonton	Alberta
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	St. Joesph's Healthcare	Hamilton	Ontario
Canada	Maisonneuve Rosemount	Montreal	Quebec
Canada	Royal Columbian Hospital	New Westminster	British Columbia
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook HSC	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario
Canada	Providence Health Care-St. Paul's Hospital	Vancouver	British Columbia
Canada	Surrey Memorial Hospital	Vancouver	British Columbia
Canada	Winnipeg Health Sciences Centre	Winnipeg	Manitoba
United States	Tuft's Medical Centre	Boston	Massachusetts
United States	Long Beach Memorial Medical Center	Long Beach	California

Sponsors (3)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada	Canadian Institutes of Health Research (CIHR), Ottawa Hospital Research Institute

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to successful extubation		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.
Secondary	ICU and hospital lengths of stay, ICU and hospital mortality, Adverse events (e.g., self -removal of endotracheal tube)		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.