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

A Randomized Trial of Daily Sedative Interruption in Critically Ill Patients Being Managed With a Sedation Protocol - A Pilot Study

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00298493
Enrollment
65
Registered
2006-03-02
Start date
2001-02-28
Completion date
2004-09-30
Last updated
2006-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Mechanical Ventilation

Keywords

ICU, Sedation strategies, Daily sedative interruption, Sedation protocols

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.

Interventions

PROCEDURESedation management strategy

Sponsors

The Physicians' Services Incorporated Foundation
CollaboratorOTHER
Mount Sinai Hospital, Canada
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. age\>18 years 2. Mechanically ventilated, with anticipated need for MV ≥ 48 hours 3. ICU team has decided to initiate continuous sedative/analgesic infusion(s) 4. informed consent.

Exclusion criteria

1. Admission after resuscitation from cardiac arrest 2. Traumatic brain injury 3. Currently receiving neuromuscular blocking agents 4. Allergy to any of the study medications 5. History of alcohol, sedative or analgesic abuse 6. History of psychiatric illness 7. Acute or chronic neurologic dysfunction 8. Administration of sedatives for \>24 hr, 9. Lack of commitment to aggressive treatment 10. Current enrollment in a related trial 11. Previous enrollment in this trial.

Design outcomes

Primary

MeasureTime frame
Duration of Mechanical Ventilation
ICU and Hospital Lengths of stay

Secondary

MeasureTime frame
Adverse events
Patient Recall
Caregiver workload

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026