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

NCT00298493 | Completed Phase 2

• 1 other identifier: MSH REB#00-0032-A
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Mechanical Ventilation

Keywords

ICU; Sedation strategies; Daily sedative interruption; Sedation protocols

Outcome Measures

Primary Outcomes (2)

• Duration of Mechanical Ventilation

• ICU and Hospital Lengths of stay

Secondary Outcomes (3)

• Adverse events

• Patient Recall

• Caregiver workload

Interventions

Sedation management strategy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age\>18 years
• Mechanically ventilated, with anticipated need for MV ≥ 48 hours
• ICU team has decided to initiate continuous sedative/analgesic infusion(s)
• informed consent.

You may not qualify if:

• Admission after resuscitation from cardiac arrest
• Traumatic brain injury
• Currently receiving neuromuscular blocking agents
• Allergy to any of the study medications
• History of alcohol, sedative or analgesic abuse
• History of psychiatric illness
• Acute or chronic neurologic dysfunction
• Administration of sedatives for \>24 hr,
• Lack of commitment to aggressive treatment
• Current enrollment in a related trial
• Previous enrollment in this trial.

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related Publications (1)

• 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.

  PMID: 18552687 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sangeeta Mehta, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 28, 2006
• First Posted: March 2, 2006
• Study Start: February 1, 2001
• Study Completion: September 1, 2004
• Last Updated: March 2, 2006

Record last verified: 2006-02

Locations

CA (1)